TORO, MEDIUM AXIAL, 3.5mm HEX

GUDID 00810019933066

A 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.

Bradshaw Medical, Inc.

Surgical screwdriver, reusable

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00810019933066 [Primary]

FDA Product Code

• HWR: Driver, Prosthesis

Sterilization

• 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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-14
• Device Publish Date: 2025-02-06

Devices Manufactured by Bradshaw Medical, Inc.

• 00810019931574 - Concentrical blade - length 50 mm: 2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m
• 00810019931598 - Concentrical blade - length 70 mm: 2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m
• 00810019931604 - Concentrical blade - length 80 mm: 2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m
• 00810019931628 - Concentrical blade - length 90 mm: 2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m
• 00810019931635 - Concentrical blade - length 100 mm: 2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m
• 00810019931642 - Concentrical blade - length 110 mm: 2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m
• 00810019931659 - Concentrical blade - length 120 mm: 2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m
• 00810019931666 - Concentrical blade - length 130 mm: 2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m