Identity
- Trade Name
- Cannulated Universal Quick Connect Handle FDA UDI
- Generic Name
- Surgical instrument handle, non-torque-limiting FDA UDI
- Device Name
- Drivers are of various tips and handle geometry and are made of stainless steel that is heat treated and passivated. Driver assembly handles are made from machined Radel. FDA UDI
- Model / Reference
- NA FDA UDI
- Description
- Drivers are of various tips and handle geometry and are made of stainless steel that is heat treated and passivated. Driver assembly handles are made from machined Radel. FDA UDI
Identifiers
- Catalog Number
- TO-DRI-M-CQCH FDA UDI
- Primary DI / UDI-DI
- 00816101013524 FDA UDI
- FDA Product Code
- HXX 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument handle, non-torque-limiting
Cannulated Universal Quick Connect Handle by Toby Orthopaedics — 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
- Toby Orthopaedics
Sources (1)
- FDA UDI e51ebe25-5174-4e02-afa4-35d2f209a4d1 35 fields · synced May 31, 2026