AccessGUDID - DEVICE: Henry Schein (00304040019481)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 1124865
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1124865
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 00304040019481
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: Self Seal Sterilization Pouch

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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 packaging, single-use	A device intended to be used to enclose medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
KCT	Sterilization wrap containers, trays, cassettes & other accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at cool dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e9214e27-aa71-4456-b0d9-d58fc9d21811
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016