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-S-CQCH FDA UDI
- Primary DI / UDI-DI
- 00816101017911 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
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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 |
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Manufacturer
- Manufacturer
- Toby Orthopaedics
Sources (1)
- FDA UDI ea9c77d2-a325-43ec-a82e-1e4f742f55f1 35 fields · synced May 30, 2026