Rod Gripper Double Action 5.5mm & 6.35mm Diameter

GUDID 00810019932717

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.

Orthopaedic counter-torque/rod-pushing instrument
Primary Device ID00810019932717
NIH Device Record Key017d23da-38c7-47ea-9af5-e456a40167d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameRod Gripper Double Action 5.5mm & 6.35mm Diameter
Version Model NumberRG-000602
Company DUNS621830582
Company NameBradshaw Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810019932717 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810019932717]

Dry Heat Sterilization


[00810019932717]

Dry Heat Sterilization


[00810019932717]

Dry Heat Sterilization


[00810019932717]

Dry Heat Sterilization


[00810019932717]

Dry Heat Sterilization


[00810019932717]

Dry Heat Sterilization


[00810019932717]

Dry Heat Sterilization


[00810019932717]

Dry Heat Sterilization


[00810019932717]

Dry Heat Sterilization


[00810019932717]

Dry Heat Sterilization


[00810019932717]

Dry Heat Sterilization


[00810019932717]

Dry Heat Sterilization


[00810019932717]

Dry Heat Sterilization


[00810019932717]

Dry Heat Sterilization


[00810019932717]

Dry Heat Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-14
Device Publish Date2025-02-06

Devices Manufactured by Bradshaw Medical, Inc.

00810019931574 - Concentrical blade - length 50 mm2025-08-20 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 mm2025-08-20 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 mm2025-08-20 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 mm2025-08-20 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 mm2025-08-20 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 mm2025-08-20 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 mm2025-08-20 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 mm2025-08-20 A concentrical blade is a specialized surgical instrument that is a component of a modular retractor system, primarily used in m

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