AccessGUDID - DEVICE: Duo-Check Heat Sealing Sterilization Pouches (10732224109968)

GUDID

Device Identifier (DI) Information

Brand Name: Duo-Check Heat Sealing Sterilization Pouches
Version or Model: SC1015HS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SC1015HS
Company Name: CROSSTEX INTERNATIONAL, INC.

Primary DI Number: 10732224109968
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 057728685 *Terms of Use

Device Description: Compatible with steam and EO sterilization. With internal and external process indicators, 10 in x 15 in

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
13735	Sterilization packaging, single-use	A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain 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.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K941327	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
Special Storage Condition, Specify: Keep Away from Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 62895e5e-1017-4ce7-b9e1-edf9f3602b86
Public Version Date: August 18, 2023
Public Version Number: 1
DI Record Publish Date: August 10, 2023