Identity
- Trade Name
- restor3d Veritas rTSA Instrumentation FDA UDI
- Generic Name
- Fluted surgical drill bit, single-use FDA UDI
- Device Name
- Ø 3.8 mm Drill Bit - solid FDA UDI
- Model / Reference
- 6500-3038 FDA UDI
- Description
- Ø 3.8 mm Drill Bit - solid FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840097515748 FDA UDI
- 510(k) Number
- K243643 FDA UDI
- FDA Product Code
- PHX FDA UDIKWS FDA UDI
- GMDN Term
- Fluted surgical drill bit, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fluted surgical drill bit, single-use
restor3d Veritas rTSA Instrumentation by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluted surgical drill bit, single-use.
- LEVEL ONE — KLS-Martin L.P. · Class I
- T2 ALPHA — Stryker Corp. · Class I
- Piccolo Composite Plate System — CARBOFIX ORTHOPEDICS LTD · Class II
- Nobel Biocare® — Nobel Biocare AG · Class I
- INSTRUMENT — Howmedica Osteonics Corp. · Class I
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- EVOS — Smith & Nephew, Inc. · Class I
- EBA ONE — Citieffe · Class II
Cleared under the same submission
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Restor3D
Sources (1)
- FDA UDI 72352e4a-6897-4126-b2d0-a068cc05a7f9 34 fields · synced May 30, 2026