Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- ENT elevator FDA UDI
- Device Name
- Austin foot plate elevator, 6 1/4'', straight shaft, angled 90 degrees, 0.33mm long blade, round handle FDA UDI
- Model / Reference
- Austin foot plate elevator FDA UDI
- Description
- Austin foot plate elevator, 6 1/4'', straight shaft, angled 90 degrees, 0.33mm long blade, round handle FDA UDI
Identifiers
- Catalog Number
- 20-125 FDA UDI
- Primary DI / UDI-DI
- 00190660032470 FDA UDI
- FDA Product Code
- KAD FDA UDI
- GMDN Term
- ENT elevator 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: ENT elevator
Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENT elevator.
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class I
- EVONOS — Gyrus Acmi, Inc. · Class I
- Integra® — Integra LifeSciences Production Corporation · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Instrumentarium — Société Chirurgicale Instrumentarium Inc · Class I
- ENDOSCOPIC FOREHEAD LIFTER — SONTEC INSTRUMENTS, INC. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · 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 ec1d45ce-4efa-472c-b664-dbe8ca0380bb 35 fields · synced May 30, 2026