Identity
- Trade Name
- TRIGEN FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, rigid FDA UDI
- Device Name
- 6.0MM SCULPTOR FIXED ENDCUTTING REAMER FDA UDI
- Model / Reference
- 71118220 FDA UDI
- Description
- 6.0MM SCULPTOR FIXED ENDCUTTING REAMER FDA UDI
Identifiers
- Catalog Number
- 71118220 FDA UDI
- Primary DI / UDI-DI
- 03596010436535 FDA UDI
- 510(k) Number
- K123598 FDA UDI
- FDA Product Code
- JDG FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, rigid FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3360 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
No
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: Medullary canal orthopaedic reamer, rigid
Trigen by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K123598 also covers:
- 'SL-PLUS¿' — Smith & Nephew, Inc.
- ANTHOLOGY — Smith & Nephew, Inc.
- ANTHOLOGY — Smith & Nephew, Inc.
- Accord — Smith & Nephew, Inc.
- Anthology — Smith & Nephew, Inc.
- Anthology — Smith & Nephew, Inc.
- Anthology — Smith & Nephew, Inc.
- Anthology — Smith & Nephew, Inc.
- Anthology — Smith & Nephew, Inc.
- Anthology — Smith & Nephew, Inc.
- CATALYSTEM — Smith & Nephew, Inc.
- CONTOUR — Smith & Nephew, Inc.
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 |
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Manufacturer
- Manufacturer
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI ef1821b2-9b07-459f-979e-c265623c0b4f 36 fields · synced Jun 8, 2026