Identity
- Trade Name
- PillCam FDA UDI
- Generic Name
- Video capsule endoscopy system antenna FDA UDI
- Device Name
- sensor array, DR2 8-lead FDA UDI
- Model / Reference
- RFB-0154 FDA UDI
- Description
- sensor array, DR2 8-lead FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290101365686 FDA UDI
- FDA Product Code
- NEZ FDA UDI
- GMDN Term
- Video capsule endoscopy system antenna FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1300 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Video capsule endoscopy system antenna
PillCam by Given Imaging , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Video capsule endoscopy system antenna.
- LEAD ANTENNA UNIT — Olympus Medical Systems Corporation · Class II
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- PillCam — Given Imaging , Ltd. · Class II
- PillCam — Given Imaging , Ltd. · Class II
- Pillcam — Given Imaging , Ltd. · Class II
- Pillcam — Given Imaging , Ltd. · Class II
- Pillcam — Given Imaging , Ltd. · Class II
- Pillcam — Given Imaging , Ltd. · 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 a6505a42-a092-4253-ad9b-b2973723ff36 35 fields · synced May 30, 2026