Identity
- Trade Name
- Ratchet Wrench FDA UDI
- Generic Name
- Surgical torque wrench, reusable FDA UDI
- Device Name
- Ratchet Wrench FDA UDI
- Model / Reference
- ET-0007 FDA UDI
- Description
- Ratchet Wrench FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290112447395 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Surgical torque wrench, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
No
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
Yes
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
MR Conditional FDA UDI
Category: Surgical torque wrench, reusable
Ratchet Wrench by Etgar - Medical Instruments Ltd — Class I — 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
- Momentum — ULRICH MEDICAL USA, INC. · Class II
- Mariner Deformity — SeaSpine Orthopedics Corporation · Class I
- 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
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Etgar - Medical Instruments Ltd
Sources (1)
- FDA UDI 8bb74cb5-b886-405d-82ab-1dab6bfa1e2f 33 fields · synced Jun 1, 2026