AccessGUDID - DEVICE: NA (04546540356574)

GUDID

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Device Identifier (DI) Information

Brand Name: NA
Version or Model: 62-00146
Catalog Number: 62-00146
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 04546540356574
Issuing Agency: GS1
Device Count: 1

Device Description: DRILL GUIDE,LAG SCREWS,1.6MM PILOT DRILL

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Surgical drill guide, reusable	A hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill size, is made of high-grade stainless steel, and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Surgical drill guide, reusable

A hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill size, is made of high-grade stainless steel, and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
HTW	BIT, DRILL

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 63.5 Millimeter
Device Size Text, specify: Diameter: 20.0 Millimeter

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: December 08, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

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Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: NA (04546540356574)