Identity
- Trade Name
- Tornier Perform FDA UDI
- Generic Name
- Drilling power tool attachment, basic FDA UDI
- Device Name
- Baseplate Post Drill FDA UDI
- Model / Reference
- MWJ158 FDA UDI
- Description
- Baseplate Post Drill FDA UDI
Identifiers
- Catalog Number
- MWJ158 FDA UDI
- Primary DI / UDI-DI
- 00846832062737 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Drilling power tool attachment, basic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 10 Millimeter FDA UDI
Category: Drilling power tool attachment, basic
Tornier Perform by Tornier, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Drilling power tool attachment, basic.
- Smith and Nephew — Provision · Class I
- Stryker — Provision · Class I
- Treace Medical Concepts — Provision · Class I
- Synthes — Provision · Class I
- Treace Medical Concepts — Provision · Class I
- GEO — Provision · Class I
- Synthes — Provision · Class I
- CrossRoads — Provision · 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
- Tornier, Inc.
Sources (1)
- FDA UDI 7f546cbc-4018-4224-9902-15e2f3c490d9 36 fields · synced Jun 1, 2026