Identity
- Trade Name
- PANTA XL FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- The PANTA XL nail set inclides instrumentation wich are used as a guide for the implantation of PANTA XL Nail system.The PANTA XL ankle nail is a straight, cannulated intramedullary nail. FDA UDI
- Model / Reference
- PANTAXLSET FDA UDI
- Description
- The PANTA XL nail set inclides instrumentation wich are used as a guide for the implantation of PANTA XL Nail system.The PANTA XL ankle nail is a straight, cannulated intramedullary nail. FDA UDI
Identifiers
- Catalog Number
- PANTAXLSET FDA UDI
- Primary DI / UDI-DI
- 10381780125884 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 Xl by Newdeal Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 c578401f-1ca4-4991-ad41-e82c47aa83d8 36 fields · synced May 31, 2026