Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Nasal chisel FDA UDI
- Device Name
- Frenchay nasal chisel, 7'', curved left, single-guarded, flat handle FDA UDI
- Model / Reference
- Frenchay nasal chisel FDA UDI
- Description
- Frenchay nasal chisel, 7'', curved left, single-guarded, flat handle FDA UDI
Identifiers
- Catalog Number
- 16-404 FDA UDI
- Primary DI / UDI-DI
- 00190660008871 FDA UDI
- FDA Product Code
- KAN FDA UDI
- GMDN Term
- Nasal chisel FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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: Nasal chisel
Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal chisel.
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- FENTEX — FENTEX medical GmbH · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- BONE CHISEL CHANDLER — W.H. Holden, Inc. · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- BONE CHISEL 3mm HD CURVED — W.H. Holden, Inc. · Class I
- West chisel — Spiggle & Theis Medizintechnik GmbH · 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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 7a18f07a-1f64-4282-a547-394d080fc4f5 35 fields · synced May 30, 2026