Identity
- Trade Name
- SCHWERT FDA UDI
- Generic Name
- Periosteal elevator, reusable FDA UDI
- Device Name
- Bone carrier mini TIN FDA UDI
- Model / Reference
- 1695-110 FDA UDI
- Description
- Bone carrier mini TIN FDA UDI
Identifiers
- Catalog Number
- 1695-110 FDA UDI
- Primary DI / UDI-DI
- E89616951100 FDA UDI
- FDA Product Code
- EKR FDA UDI
- GMDN Term
- Periosteal elevator, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Periosteal elevator, reusable
This bone carrier mini TIN device is a hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. Made of metal [e.g., stainless steel, titanium (Ti)], this is a reusable device.
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
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- A. Schweickhardt GmbH & Co. KG
Sources (1)
- FDA UDI 0d9526c4-dc1a-43ec-b656-6cdc5f2a71b2 35 fields · synced Jul 24, 2026