AccessGUDID - DEVICE: NA (04546540755865)

GUDID

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Device Identifier (DI) Information

Brand Name: NA
Version or Model: 234-020-085
Catalog Number: 234-020-085
Company Name: STRYKER CORPORATION

Primary DI Number: 04546540755865
Issuing Agency: GS1
Device Count: 1

Device Description: GRAFT SIZING GAUGE 6MM

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

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

GMDN Preferred Term Name	GMDN Definition
Orthopaedic graft sizer	A non-sterile surgical instrument that contains a series of holes of varying diameters intended to be used in orthopaedic surgery [e.g., in anterior cruciate ligament (ACL) reconstruction surgery] to determine the size of a graft to be implanted. It is used in vitro [e.g., on the preparation table of the operating room (OR)] on a harvested graft. The measurement is subsequently used to determine the diameter of the holes drilled into the site (e.g., distal femur) for acceptance of the new graft. The device may be made of polysulfone. This is a reusable device intended to be sterilized prior to use.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic graft sizer

A non-sterile surgical instrument that contains a series of holes of varying diameters intended to be used in orthopaedic surgery [e.g., in anterior cruciate ligament (ACL) reconstruction surgery] to determine the size of a graft to be implanted. It is used in vitro [e.g., on the preparation table of the operating room (OR)] on a harvested graft. The measurement is subsequently used to determine the diameter of the holes drilled into the site (e.g., distal femur) for acceptance of the new graft. The device may be made of polysulfone. This is a reusable device intended to be sterilized prior to use.

FDA Product Code

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Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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

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Size Type Text
Lumen/Inner Diameter: 6.0 Millimeter

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 09, 2015
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 (04546540755865)