Identity
- Trade Name
- 5.5mm LUMBAR ROD GRIPPER FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- The Rod Gripper is a medical device designed to deliver a seamless surgical experience when maneuvering surgical rods that are used to facilitate the required surgical intervention. The Rod Gripper medical device family, including specific sizes like the Ø5.5mm version, are medical devices that are used to capture, retain, and manipulate implantable rods during orthopedic surgeries FDA UDI
- Model / Reference
- LRG-608 FDA UDI
- Description
- The Rod Gripper is a medical device designed to deliver a seamless surgical experience when maneuvering surgical rods that are used to facilitate the required surgical intervention. The Rod Gripper medical device family, including specific sizes like the Ø5.5mm version, are medical devices that are used to capture, retain, and manipulate implantable rods during orthopedic surgeries FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810019933295 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General internal orthopaedic fixation system implantation kit
5.5mm LUMBAR ROD GRIPPER by Bradshaw Medical Inc. — 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
- Bradshaw Medical Inc.
Sources (1)
- FDA UDI dc71c735-69bf-446c-b0fc-db9c1f843af8 33 fields · synced May 30, 2026