| Primary Device ID | 00810019933066 |
| NIH Device Record Key | aca16fd8-7d5f-4c70-bc53-64e434d4c25c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TORO, MEDIUM AXIAL, 3.5mm HEX |
| Version Model Number | 804-06-009 |
| Company DUNS | 621830582 |
| Company Name | Bradshaw Medical, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810019933066 [Primary] |
| HWR | Driver, Prosthesis |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00810019933066]
Dry Heat Sterilization
[00810019933066]
Dry Heat Sterilization
[00810019933066]
Dry Heat Sterilization
[00810019933066]
Dry Heat Sterilization
[00810019933066]
Dry Heat Sterilization
[00810019933066]
Dry Heat Sterilization
[00810019933066]
Dry Heat Sterilization
[00810019933066]
Dry Heat Sterilization
[00810019933066]
Dry Heat Sterilization
[00810019933066]
Dry Heat Sterilization
[00810019933066]
Dry Heat Sterilization
[00810019933066]
Dry Heat Sterilization
[00810019933066]
Dry Heat Sterilization
[00810019933066]
Dry Heat Sterilization
[00810019933066]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-14 |
| Device Publish Date | 2025-02-06 |
| 00810019932908 - ROD-GRIPPER LUMBAR DUAL ACTION 5.5MM SILICONE OVERMOLD | 2025-03-06 A lumbar spinal fixation component, the ROD-GRIPPER, featuring a dual-action locking mechanism and a 5.5mm silicone overmold. De |
| 00810019932915 - 5.5mm LUMBAR ROD GRIPPER | 2025-03-06 the 5.5mm LUMBAR ROD GRIPPER is a crucial element in spinal surgery, contributing to the stability and long-term success of spin |
| 00810019932717 - Rod Gripper Double Action 5.5mm & 6.35mm Diameter | 2025-02-14 A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduc |
| 00810019933066 - TORO, MEDIUM AXIAL, 3.5mm HEX | 2025-02-14A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device. |
| 00810019933066 - TORO, MEDIUM AXIAL, 3.5mm HEX | 2025-02-14 A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduc |
| 00810019932632 - Bradshaw Medical, Inc. | 2024-03-04 C-Torq, Cerv Dual Claw |
| 00810019932526 - Bradshaw Medical Inc. | 2024-02-06 TLIF DISTRACTOR 5.5 / 6.0 |
| 00810019932533 - Bradshaw Medical Inc. | 2024-02-06 COMPRESSOR 5.5 / 6.0 HINGED |
| 00810019932540 - Bradshaw Medical Inc. | 2024-02-06 DISTRACTOR 5.5 / 6.0, HINGED |