Identity
- Trade Name
- Frazier Dorsey Dura Separator FDA UDI
- Generic Name
- Periosteal elevator, reusable FDA UDI
- Device Name
- Frazier Dorsey Dura Separator 5 X 15 Millimeter Blade FDA UDI
- Model / Reference
- 412-488 FDA UDI
- Description
- Frazier Dorsey Dura Separator 5 X 15 Millimeter Blade FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00192896112353 FDA UDI
- FDA Product Code
- HTE 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
Dimensions & Sizes
- Size
- Length — 6 Inch FDA UDI
Category: Periosteal elevator, reusable
Frazier Dorsey Dura Separator by Sontec Instruments, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Periosteal elevator, reusable.
- Ambler Surgical — Ambler Surgical, LLC · Class I
- 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
- Ambler Surgical — Ambler Surgical, 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
- Sontec Instruments, Inc.
Sources (1)
- FDA UDI 88649b24-1f4e-43d2-b184-08e330dbf73c 35 fields · synced May 30, 2026