Identity
- Trade Name
- GIFD FDA UDI
- Generic Name
- Video capsule endoscopy system monitor FDA UDI
- Device Name
- GIFD laptop, Win 10 with SW FDA UDI
- Model / Reference
- FGS-0671 FDA UDI
- Description
- GIFD laptop, Win 10 with SW FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290110361068 FDA UDI
- FDA Product Code
- FFX FDA UDI
- GMDN Term
- Video capsule endoscopy system monitor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1725 FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Over-the-Counter
No
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
Category: Video capsule endoscopy system monitor
Gifd by Given Imaging , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Video capsule endoscopy system monitor.
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- PillCam — Given Imaging , Ltd. · Class II
Cleared under the same submission
K151086 also covers:
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 |
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Manufacturer
- Manufacturer
- Given Imaging , Ltd.
Sources (1)
- FDA UDI f6511d93-7b11-42ff-8cf1-6232d365f8ff 35 fields · synced May 30, 2026