# FDA AccessGUDID Device Identifier (DI) Lookup & Record Verification
> Lookup and validate medical device Device Identifiers (UDI-DI) directly against FDA AccessGUDID data dictionary specifications.

- **Canonical URL:** https://stanzaapi.com/tools/udi-decoder/standard/accessgudid-di-lookup
- **Governing Standard:** FDA 21 CFR 801.20 / EU MDR 2017/745 (FDA AccessGUDID Database & IMDRF)
- **Latency:** <2ms Edge
- **Privacy:** In-memory execution only (zero data stored or logged)

## Technical Overview & Governing Rules
FDA AccessGUDID serves as the authoritative public repository for medical device records mandated under 21 CFR § 801.40. StanzaAPI provides instant validation of Primary DI syntax and attribute verification.

## Specification Matrix
| 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 |

## Standard JSON Response Model
```json
{
  "accessgudidStatus": "VERIFIED",
  "primaryDi": "00884838012345",
  "issuingAgency": "GS1",
  "brandName": "PrecisionPulse Titanium Implantable Lead",
  "modelNumber": "PL-4500X",
  "premarketNumber": "K241289",
  "mriSafety": "MR Conditional",
  "commercialDistribution": "In Commercial Distribution"
}
```

## Frequently Asked Questions & Edge Cases
### Q: What is the format of an FDA AccessGUDID Primary DI?
**A:** 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.

### Q: Can StanzaAPI query live FDA AccessGUDID records?
**A:** Yes. StanzaAPI 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.