Identity
- Trade Name
- Viscera Retainer, Fish FDA UDI
- Generic Name
- Viscera retention paddle FDA UDI
- Device Name
- Pediatric Viscera Retainer FDA UDI
- Model / Reference
- 3200 FDA UDI
- Description
- Pediatric Viscera Retainer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00613244000011 FDA UDI
- 510(k) Number
- K802806 FDA UDI
- FDA Product Code
- GCZ FDA UDI
- GMDN Term
- Viscera retention paddle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Viscera retention paddle
Viscera Retainer, Fish by Adept Med International Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Viscera Retainer Radiopaque Center Spine — RAINBOW MEDICAL DEVICES LLC · Class I
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- Viscera Retainer Radiopaque Center Spine — RAINBOW MEDICAL DEVICES LLC · Class I
Cleared under the same submission
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 I | Pending data |
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Manufacturer
- Manufacturer
- Adept Med International Inc
Sources (1)
- FDA UDI 4184d4a3-1d0a-4c58-9f5e-4f09de06c441 35 fields · synced Jun 1, 2026