Identity
- Trade Name
- PANTA® FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, single-use FDA UDI
- Device Name
- The classical reamer of diameter 11.5 mm and of total length 300 mm is used to ream the intramedullary canal to prepare the nail insertion. FDA UDI
- Model / Reference
- 519015ND FDA UDI
- Description
- The classical reamer of diameter 11.5 mm and of total length 300 mm is used to ream the intramedullary canal to prepare the nail insertion. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780045090 FDA UDI
- FDA Product Code
- HTO 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
Similar devices
Also classified as Bone-resection orthopaedic reamer, single-use.
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- Disposable — Biomet Orthopedics, Inc. · Class I
- ACETABULAR REAMER EVO 2 Ti CUP D42 mm — HPF SRL · Class I
- 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 14a713e7-c29b-4f6d-b622-01c2e7972127 36 fields · synced May 29, 2026