Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Periosteal elevator, reusable FDA UDI
- Device Name
- Gunter elevator, 7 1/2'', double-ended, sharp, 4.5mm and 6.0mm wide blades, round handle FDA UDI
- Model / Reference
- Gunter elevator FDA UDI
- Description
- Gunter elevator, 7 1/2'', double-ended, sharp, 4.5mm and 6.0mm wide blades, round handle FDA UDI
Identifiers
- Catalog Number
- 20-375 FDA UDI
- Primary DI / UDI-DI
- 00190660033651 FDA UDI
- FDA Product Code
- GEG FDA UDI
- GMDN Term
- Periosteal elevator, reusable 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: Periosteal elevator, reusable
Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Periosteal elevator, reusable.
- STERLING — BENCO DENTAL SUPPLY CO. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- SCANLAN® Instrumentation — SCANLAN INTERNATIONAL INC · Class I
- BARRIER PLACEMENT INSTRUMENT — W.H. Holden, Inc. · Class I
- ELEVATOR — KLS-Martin L.P. · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- ZOLL-DENTAL — Zoll-Dental · Class I
- gSource — GSOURCE, 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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 66eecb9a-3cc3-41cb-8aa5-de22e51edbfe 35 fields · synced Jun 6, 2026