Identity
- Trade Name
- Outer Sheath W/ Handle FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Model / Reference
- 110008434 FDA UDI
Identifiers
- Catalog Number
- 110008434 FDA UDI
- Primary DI / UDI-DI
- 00887868463174 FDA UDI
- 510(k) Number
- K140891 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting 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
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: Surgical instrument handle, non-torque-limiting
Outer Sheath W/ Handle by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical instrument handle, non-torque-limiting.
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- IDOL — İDOL HASTANE ÜRÜN. SAN. VE TİC. A.Ş. · Class I
- Tecomet — Tecomet,Inc · Class I
- Equinoxe — Exactech, Inc. · Class II
- Kinectiv® — Zimmer, Inc. · Class I
- CUSTOM U JOINT DRIVER — Zimmer, Inc. · Class I
Cleared under the same submission
K140891 also covers:
- Biomet Cannulated Screw System — Biomet Orthopedics, Inc.
- CANNULATED SCREW 4.0MM X 10MM (FULL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 4.0MM X 16MM (PARTIAL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 4.0MM X 22MM (PARTIAL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 4.0MM X 50MM (PARTIAL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 4.0MM X 55MM (FULL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 4.0MM X 65MM (FULL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 4.0MM X 70MM (PARTIAL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 5.0MM X 34MM (FULL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 5.0MM X 34MM (FULL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 5.0MM X 44MM (FULL THREAD) — Biomet Orthopedics, Inc.
- CANNULATED SCREW 5.0MM X 95MM (FULL THREAD) — Biomet Orthopedics, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI dd0495af-b4b1-4245-8355-200a9539893b 35 fields · synced Jun 1, 2026