Identity
- Trade Name
- FENTEX FDA UDI
- Generic Name
- Chisel/osteotome blade handle FDA UDI
- Device Name
- Handle by Heermann for 164110FX-130FX and 532113 -216FX 9 cm FDA UDI
- Model / Reference
- 164300FX FDA UDI
- Description
- Handle by Heermann for 164110FX-130FX and 532113 -216FX 9 cm FDA UDI
Identifiers
- Catalog Number
- 164300FX FDA UDI
- Primary DI / UDI-DI
- 04250407717155 FDA UDI
- FDA Product Code
- LRC FDA UDI
- GMDN Term
- Chisel/osteotome blade handle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Chisel/osteotome blade handle
Fentex by FENTEX medical GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Chisel/osteotome blade handle.
- Spinal System — BIOMET SPINE LLC · Class I
- Reicodent — devemed GmbH · Class I
- Spinal System — BIOMET SPINE LLC · Class I
- Varian Ethos Radiotherapy System — Varian Medical Systems, Inc · Class II
- ROI-A — Ldr Spine USA · Class II
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- PediLoc, PLEO — ORTHOPEDIATRICS CORP. · Class I
- Spinal System — BIOMET SPINE LLC · 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
- FENTEX medical GmbH
Sources (1)
- FDA UDI 4bbc54d6-020e-434a-b8ae-e0fa930fe933 35 fields · synced May 30, 2026