AccessGUDID - DEVICE: NA (04546540364784)

GUDID

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Device Identifier (DI) Information

Brand Name: NA
Version or Model: 29-20230
Catalog Number: 29-20230
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 04546540364784
Issuing Agency: GS1
Device Count: 1

Device Description: MANDIBLE FIXATION MODULE

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
Sterilization container	A receptacle designed to hold unwrapped surgical instruments, typically devices such as surgical powered drills and saws along with their hoses, during sterilization and for their subsequent storage. The container is permeable in order to allow moisture to escape from within after the sterilization process is finished, whilst protecting the contents from being contaminated. It may have features such as an expiry date label, sterile breathing filter, and stacking capabilities. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Sterilization container

A receptacle designed to hold unwrapped surgical instruments, typically devices such as surgical powered drills and saws along with their hoses, during sterilization and for their subsequent storage. The container is permeable in order to allow moisture to escape from within after the sterilization process is finished, whilst protecting the contents from being contaminated. It may have features such as an expiry date label, sterile breathing filter, and stacking capabilities. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
FSM	TRAY, 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
No Device Sizes

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 (04546540364784)