Identity
- Trade Name
- AGILON® FDA UDI
- Generic Name
- Orthopaedic chisel FDA UDI
- Device Name
- box chisel universal FDA UDI
- Model / Reference
- 78010156 FDA UDI
- Description
- box chisel universal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048844620004 FDA UDI
- FDA Product Code
- HSD FDA UDIPHX FDA UDI
- GMDN Term
- Orthopaedic chisel FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3690 FDA UDI888.3660 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
No
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
No
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: Orthopaedic chisel
Improve your orthopaedic surgery with the AGILON box chisel universal, a single-blade surgical instrument designed to cut and shape bone. This hand-held device features a bevelled on one side for easy use and is made entirely of metal or has a handle made of synthetic material.
Similar devices
Also classified as Orthopaedic chisel.
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
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- CHISEL — KLS-Martin L.P. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- gSource — GSOURCE, LLC. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Novo Surgical — NOVO SURGICAL, 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 II | Pending data |
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Manufacturer
- Manufacturer
- implantcast GmbH
Sources (1)
- FDA UDI a5055e37-1f14-4692-87ab-e6edff9ee918 33 fields · synced Jul 19, 2026