Bradshaw Medical

GUDID 00810019931994

The Rod Gripper of Bradshaw Medical Inc (dba Intech) is a Class 1r device designed to deliver a seamless surgical experience when maneuvering surgical rods. This surgical medical device is customized with the client’s logo, color, and textures. The Rod Gripper is shipped non-sterile and must be sterilized per the recommended instructions before use in the surgical setting. This device must be handled with care and must be used by experienced medical professionals and other individuals with appropriate training. If used within the guidelines of this document, this device will maintain a high level of performance for the life of the device. Failure to abide by such guidelines could significantly compromise the performance of the device and cause serious injury. Due to the nature of this device, there is no specific demographic that this product is to be used with. The Rod Gripper does not have an indicative characteristic. This device is used to facilitate the required surgical intervention. Bradshaw Medical Inc. (dba Intech) is not aware of any contraindications with regards to the Rod Gripper but continues to monitor the use and application of these devices. Use as intended only.

BRADSHAW MEDICAL, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00810019931994
• NIH Device Record Key: 8e5c5b8c-3188-44a8-86aa-c89c7e6c2210
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bradshaw Medical
• Version Model Number: LRG-601
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810019931994 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

[00810019931994]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-22
• Device Publish Date: 2022-03-14

On-Brand Devices [Bradshaw Medical]

• 00810019931529: Handheld Ratcheting Rod Cutter,3.2mm, 3.5mm Silpad Black Sold as OEM
• 00810019931994: The Rod Gripper of Bradshaw Medical Inc (dba Intech) is a Class 1r device designed to deliver a