Identity
- Trade Name
- PillCam FDA UDI
- Generic Name
- Video capsule endoscopy system capsule FDA UDI
- Device Name
- COLON 2 capsule, 10-pack FDA UDI
- Model / Reference
- FGS-0522 FDA UDI
- Description
- COLON 2 capsule, 10-pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290101364832 FDA UDI
- FDA Product Code
- PGD FDA UDI
- GMDN Term
- Video capsule endoscopy system capsule FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1330 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Video capsule endoscopy system capsule
PillCam by Given Imaging , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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- NaviCam Capsule Endoscope System — ANX ROBOTICA CORP. · Class II
- NaviCam Tether — ANX ROBOTICA CORP. · Class II
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 2a6d5b2f-42c9-4605-9425-e035c0524563 35 fields · synced May 30, 2026