Identity
- Trade Name
- SMALL BLUE D.A.F. FDA UDI
- Generic Name
- Surgical torque wrench, reusable FDA UDI
- Device Name
- TORQUE WRENCH 5 MM FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- TORQUE WRENCH 5 MM FDA UDI
Identifiers
- Catalog Number
- 30025 FDA UDI
- Primary DI / UDI-DI
- 18032568035674 FDA UDI
- 510(k) Number
- K955848 FDA UDI
- FDA Product Code
- JDW FDA UDI
- GMDN Term
- Surgical torque wrench, 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Width — 5 Millimeter FDA UDI
Category: Surgical torque wrench, reusable
Small Blue D.a.f. by Orthofix, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical torque wrench, reusable.
- XIA 3 — Stryker Corp. · Class I
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- Zavation — ZAVATION · Class II
- IMHS — Smith & Nephew, Inc. · Class II
- OXFORD ANKLE FUSION NAIL(AFN) SYSTEM — ORTHO SOLUTIONS HOLDINGS LIMITED · Class II
- X FIX — Biomet Orthopedics, Inc. · Class I
- BIONNOVATION — BIONNOVATION PRODUTOS BIOMEDICOS LTDA. · Class I
Cleared under the same submission
K955848 also covers:
- ADULT LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- ADULT LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- ADULT LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- ADVANCED LIMB RECONSTRUCTION SYSTEM — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, Inc.
- Bone Screws — Orthofix, 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
- Orthofix, Inc.
Sources (1)
- FDA UDI 85147e84-23ef-458a-bae3-2dfb5a9b0bcf 37 fields · synced Jun 1, 2026