Identity
- Trade Name
- Integra® FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Integra®Surgical Instruments The Integra Surgical Instruments mini ratchet handle is provided green in color. FDA UDI
- Model / Reference
- RM1011S03 FDA UDI
- Description
- Integra®Surgical Instruments The Integra Surgical Instruments mini ratchet handle is provided green in color. FDA UDI
Identifiers
- Catalog Number
- RM1011-S03 FDA UDI
- Primary DI / UDI-DI
- 10381780247043 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical instrument handle, non-torque-limiting FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument handle, non-torque-limiting
Integra® by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument handle, non-torque-limiting.
- SpineTune TL — Ldr Spine USA · Class I
- Acetabular Reamer Driver, Straight — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Fusion Taper Remover Screw Grip — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- 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
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
- Ascension Orthopedics, Inc.
Sources (1)
- FDA UDI e8604ca5-99a0-4f91-8195-0d2bee1448fe 37 fields · synced Jun 1, 2026