FDA AccessGUDID Device Identifier (DI) Lookup & Record Verification
Lookup and validate medical device Device Identifiers (UDI-DI) directly against FDA AccessGUDID data dictionary specifications.
Quick Technical Summary: Lookup and validate medical device Device Identifiers (UDI-DI) directly against FDA AccessGUDID data dictionary specifications. Implementation conforms to FDA 21 CFR 801.20 / EU MDR 2017/745.
Specification & Structural Breakdown
FDA AccessGUDID serves as the authoritative public repository for medical device records mandated under 21 CFR § 801.40. Stanza provides instant validation of Primary DI syntax and attribute verification.
| Attribute | Specification | Requirement | Description |
|---|---|---|---|
| Primary DI Number | GTIN-14 / HIBC Primary / ISBT 128 | Mandatory | Unique master identifier assigned to the base package level |
| Issuing Agency | GS1 | HIBCC | ICCBBA | Mandatory | FDA-accredited issuing agency responsible for the symbology |
| Brand Name | 1-255 Characters | Mandatory | Commercial proprietary trade name of the medical device |
| Version / Model Number | 1-50 Characters | Conditional | Manufacturer internal catalog, reference, or model code |
| Premarket Number | 510(k) / PMA / De Novo | Conditional | FDA regulatory clearance number (e.g. K123456 or P123456) |
| GMDN Code / CTG | Global Medical Device Nomenclature | Mandatory | International standardized medical nomenclature classification |
| MRI Safety Status | Safe | Conditional | Unsafe | Mandatory | ASTM F2503 magnetic resonance imaging safety rating |
| Commercial Distribution | In Commercial Distribution | Off Market | Mandatory | Active lifecycle distribution state in the United States |
Test FDA AccessGUDID Device Identifier (DI) Lookup & Record Verification Live
Paste raw inputs up to 32KB and inspect deterministic parsed JSON in real-time across 330+ Cloudflare edge locations. Pure compute, zero cold-starts.
Parsed JSON Response Model
The edge microservice transforms input payloads into strongly-typed hierarchical JSON with zero cold starts:
{
"accessgudidStatus": "VERIFIED",
"primaryDi": "00884838012345",
"issuingAgency": "GS1",
"brandName": "PrecisionPulse Titanium Implantable Lead",
"modelNumber": "PL-4500X",
"premarketNumber": "K241289",
"mriSafety": "MR Conditional",
"commercialDistribution": "In Commercial Distribution"
}
Copy-Paste Integration Code
Integrate this validator directly into your application using your production API key:
curl --request POST \
--url "https://fda-eu-mdr-medical-device-udi-decoder-gs1-hibcc-iccbba.stanzaapi.com/api/v1/udi/decode" \
--header "Content-Type: application/json" \
--header "x-api-key: YOUR_API_KEY" \
--data '{
"udi": "(01)00884838012345(17)260831(10)LOT7788(21)SN991823"
}'
const response = await fetch("https://fda-eu-mdr-medical-device-udi-decoder-gs1-hibcc-iccbba.stanzaapi.com/api/v1/udi/decode", {
method: "POST",
headers: {
"Content-Type": "application/json",
"x-api-key": process.env.API_KEY || "YOUR_API_KEY"
},
body: JSON.stringify({
"udi": "(01)00884838012345(17)260831(10)LOT7788(21)SN991823"
})
});
const data = await response.json();
console.log(data);
import requests
import json
url = "https://fda-eu-mdr-medical-device-udi-decoder-gs1-hibcc-iccbba.stanzaapi.com/api/v1/udi/decode"
headers = {
"Content-Type": "application/json",
"x-api-key": "YOUR_API_KEY"
}
payload = {
"udi": "(01)00884838012345(17)260831(10)LOT7788(21)SN991823"
}
response = requests.post(url, json=payload, headers=headers)
print(response.json())
package main
import (
"bytes"
"fmt"
"io"
"net/http"
"os"
)
func main() {
url := "https://fda-eu-mdr-medical-device-udi-decoder-gs1-hibcc-iccbba.stanzaapi.com/api/v1/udi/decode"
payload := []byte(`{"udi":"(01)00884838012345(17)260831(10)LOT7788(21)SN991823"}`)
req, _ := http.NewRequest("POST", url, bytes.NewBuffer(payload))
req.Header.Add("Content-Type", "application/json")
req.Header.Add("x-api-key", os.Getenv("API_KEY"))
res, err := http.DefaultClient.Do(req)
if err != nil {
panic(err)
}
defer res.Body.Close()
body, _ := io.ReadAll(res.Body)
fmt.Println(string(body))
}
Frequently Asked Questions & Technical Notes
Primary DIs must strictly conform to GS1 GTIN-14 (14 digits numeric with Modulo-10 check digit), HIBCC (+LIC followed by product code and Mod-43), or ICCBBA ISBT 128.
Yes. Stanza provides an optional Ultra/Enterprise live GUDID lookup bridge (/api/v1/udi/live) that resolves real-time FDA catalog records with edge-cached sub-10ms response times.
Related Medical Device UDI Barcode & AIDC Engine Formats
Explore sibling specifications and standards in the same developer cluster:
GS1 UDI Barcode Format & AI Parser Guide (GS1-128 & DataMatrix)
Parse GS1-128 linear barcodes and 2D DataMatrix medical device UDIs into structured DI/PI attributes in milliseconds.
View Format →HIBCC Medical Device Barcode Decoder & Modulo-43 Checksum Spec
Parse primary and secondary HIBCC medical barcodes with Modulo-43 check character validation.
View Format →ICCBBA ISBT 128 Medical Device & Cellular Therapy UDI Spec
Decode ICCBBA ISBT 128 medical and biologics identifiers for human cells, tissues, and cellular products.
View Format →FDA Global UDI Database (GUDID) Submission & Compliance Spec
Validate medical device UDI records against FDA GUDID data requirements before submitting to the FDA.
View Format →