Identity
- Trade Name
- Prosthetic Kit Tray (empty) FDA UDI
- Generic Name
- Medical device integration rack FDA UDI
- Model / Reference
- PK-E FDA UDI
Identifiers
- Catalog Number
- PK-E FDA UDI
- Primary DI / UDI-DI
- 10841307124696 FDA UDI
- GMDN Term
- Medical device integration rack FDA UDI
Classification
- 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical device integration rack
Prosthetic Kit Tray (empty) by Implant Direct Sybron Manufacturing Llc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Implant Direct Sybron Manufacturing Llc
Sources (1)
- FDA UDI 17a3a55b-b079-45c6-83b3-8e7264e40173 34 fields · synced Jun 1, 2026