Identity
- Trade Name
- DFS STANDARD FIXATOR SYSTEM FDA UDI
- Generic Name
- Medical device service rail clamp FDA UDI
- Model / Reference
- 01250 FDA UDI
Identifiers
- Catalog Number
- 01250 FDA UDI
- Primary DI / UDI-DI
- 00887868080852 FDA UDI
- FDA Product Code
- KTT FDA UDI
- GMDN Term
- Medical device service rail clamp FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Medical device service rail clamp
Dfs Standard Fixator System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medical device service rail clamp.
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- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class I
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Cleared under the same submission
K081244 also covers:
- CONSTRUX EXTERNAL FIXATION SYSTEM — Biomet Orthopedics, Inc.
- DFS ANTERIOR ANGULAR HINGE — Biomet Orthopedics, Inc.
- DFS BONE SCREWS — Biomet Orthopedics, Inc.
- DFS BONE SCREWS — Biomet Orthopedics, Inc.
- DFS BONE SCREWS — Biomet Orthopedics, Inc.
- DFS BONE SCREWS — Biomet Orthopedics, Inc.
- DFS BONE SCREWS — Biomet Orthopedics, Inc.
- DFS BONE SCREWS — Biomet Orthopedics, Inc.
- DFS BONE SCREWS — Biomet Orthopedics, Inc.
- DFS BONE SCREWS — Biomet Orthopedics, Inc.
- DFS BONE SCREWS — Biomet Orthopedics, Inc.
- DFS Bone Screws — Biomet Orthopedics, Inc.
K953406 also covers:
- CONSTRUX EXTERNAL FIXATION SYSTEM — Biomet Orthopedics, Inc.
- CONSTRUX EXTERNAL FIXATION SYSTEM — Biomet Orthopedics, Inc.
- DFS ADULT RAIL — Biomet Orthopedics, Inc.
- DFS ADULT RAIL — Biomet Orthopedics, Inc.
- DFS ADULT RAIL — Biomet Orthopedics, Inc.
- DFS ADULT RAIL — Biomet Orthopedics, Inc.
- DFS ANTERIOR ANGULAR HINGE — Biomet Orthopedics, Inc.
- DFS BONE SCREWS — Biomet Orthopedics, Inc.
- DFS BONE SCREWS — Biomet Orthopedics, Inc.
- DFS BONE SCREWS — Biomet Orthopedics, Inc.
- DFS BONE SCREWS — Biomet Orthopedics, Inc.
- DFS BONE SCREWS — 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 e2644dab-528c-4b32-8571-e84c15a8caf0 35 fields · synced Jun 1, 2026