Identity
- Trade Name
- PANTA FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- The PANTA nail set inclides instrumentation wich are used as a guide for the implantation of PANTA Nail system.The PANTA ankle nail is a straight, cannulated intramedullary nail. FDA UDI
- Model / Reference
- PANTAINSTSET FDA UDI
- Description
- The PANTA nail set inclides instrumentation wich are used as a guide for the implantation of PANTA Nail system.The PANTA ankle nail is a straight, cannulated intramedullary nail. FDA UDI
Identifiers
- Catalog Number
- PANTAINSTSET FDA UDI
- Primary DI / UDI-DI
- 10381780125860 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Panta by Newdeal Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K050882 also covers:
K091788 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
- Newdeal Sas
Sources (1)
- FDA UDI 0b38391a-5129-4924-9270-8d7142b7bc3c 37 fields · synced Jun 8, 2026