AccessGUDID - DEVICE: Henry Schein (00304040006009)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 1012226
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1012226
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 00304040006009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: Sterilization Tubing Cont Clr

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:	Yes
Prescription Use (Rx):	No
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
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

[?]

Product Code	Product Code Name
FRG	Wrap, sterilization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K870147	000

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
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Width: 4 Inch

Device Record Status

Public Device Record Key: 82665972-4ec0-4eeb-a83b-bb7b3bd7a3c5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016