Identity
- Trade Name
- GENESIS FDA UDI
- Generic Name
- Orthopaedic trocar blade, reusable FDA UDI
- Device Name
- GENESIS SPECIAL TROCAR PIN 1/8 IN X 3 IN FDA UDI
- Model / Reference
- 71927250 FDA UDI
- Description
- GENESIS SPECIAL TROCAR PIN 1/8 IN X 3 IN FDA UDI
Identifiers
- Catalog Number
- 71927250 FDA UDI
- Primary DI / UDI-DI
- 03596010566690 FDA UDI
- 510(k) Number
- K120871 FDA UDI
- FDA Product Code
- JDW FDA UDI
- GMDN Term
- Orthopaedic trocar blade, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic trocar blade, reusable
Genesis 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
K120871 also covers:
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- CALANDRUCCIO II — Smith & Nephew, Inc.
- CHS — Smith & Nephew, Inc.
- Cannulated Screws — Smith & Nephew, Inc.
- GENESIS — Smith & Nephew, Inc.
- ILIZAROV — Smith & Nephew, Inc.
- ILIZAROV SYSTEMS — Smith & Nephew, Inc.
- ILIZAROV SYSTEMS — Smith & Nephew, Inc.
- ILIZAROV SYSTEMS — Smith & Nephew, Inc.
- ILIZAROV SYSTEMS — Smith & Nephew, Inc.
- ILIZAROV SYSTEMS — Smith & Nephew, Inc.
- ILIZAROV SYSTEMS — 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 a0711589-3bad-40b4-84be-7b890198c4a9 36 fields · synced Jun 8, 2026