Identity
- Trade Name
- Medicon FDA UDI
- Generic Name
- Orthopaedic bone-fragment manipulator, single-use FDA UDI
- Device Name
- Repositioning pin 95mm FDA UDI
- Model / Reference
- 68.50.13 FDA UDI
- Description
- Repositioning pin 95mm FDA UDI
Identifiers
- Catalog Number
- 68.50.13 FDA UDI
- Primary DI / UDI-DI
- 04046826543310 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic bone-fragment manipulator, 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
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
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
MR Unsafe FDA UDI
Category: Orthopaedic bone-fragment manipulator, single-use
Medicon by Medicon eG. Chirurgiemechaniker-Genossenschaft — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone-fragment manipulator, single-use.
- Tiger — Trilliant Surgical LLC · Class II
- DynaNail Mini — Medshape, Inc. · Class I
- Tiger — Trilliant Surgical LLC · Class II
- EF1 — Medshape, Inc. · Class I
- Evolve34 — Medshape, Inc. · Class I
- Tiger — Trilliant Surgical LLC · Class II
- Tiger — Trilliant Surgical LLC · Class II
- DynaNail — Medshape, Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medicon eG. Chirurgiemechaniker-Genossenschaft
Sources (1)
- FDA UDI fe033577-f82c-4e49-aba8-850f7a2345d7 34 fields · synced May 30, 2026