Identity
- Trade Name
- PANTA® FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, single-use FDA UDI
- Device Name
- The conical reamer of diameter 10.5 mm and of total length 350 mm for Panta® XL Nail is used to ream the intramedullary canal to prepare the nail insertion. FDA UDI
- Model / Reference
- 539020ND FDA UDI
- Description
- The conical reamer of diameter 10.5 mm and of total length 350 mm for Panta® XL Nail is used to ream the intramedullary canal to prepare the nail insertion. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780045601 FDA UDI
- FDA Product Code
- HTW FDA UDI
- GMDN Term
- Bone-resection orthopaedic reamer, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone-resection orthopaedic reamer, single-use
Panta® by Newdeal Sas — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone-resection orthopaedic reamer, single-use.
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- Disposable — Biomet Orthopedics, Inc. · Class I
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- Arthrex® — Arthrex, Inc. · Class I
- Tools - UFC — Trimed, INC. · Class I
- Phantom® Fibula Nail System — Paragon 28 · Class I
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
- Newdeal Sas
Sources (1)
- FDA UDI e72ca4ba-b7c1-406a-b301-f6d2aa313a5f 36 fields · synced May 31, 2026