Identity
- Trade Name
- RAPID FDA UDI
- Generic Name
- Video capsule endoscopy system application software FDA UDI
- Device Name
- Access SW kit, v7.0 WS FDA UDI
- Model / Reference
- FGS-0434 FDA UDI
- Description
- Access SW kit, v7.0 WS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290101362784 FDA UDI
- FDA Product Code
- NEZ FDA UDI
- GMDN Term
- Video capsule endoscopy system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1300 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Rapid by Given Imaging , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Given Imaging , Ltd.
Sources (1)
- FDA UDI b11818b9-99d3-4d1c-ac36-9aeefed22e8b 36 fields · synced May 30, 2026