AccessGUDID - DEVICE: NA (10724995003040)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 886049
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 886049
Company Name: STERIS CORPORATION

Primary DI Number: 10724995003040
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 961394798 *Terms of Use

Device Description: The Vis-U-All Low Temperature Self Seal Pouch is used in the V-PRO Low Temperature Sterilization Systems and STERRAD NX, 100S and 100NX sterilizers.

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):	Yes
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
FRG	Wrap, sterilization
KCT	Sterilization wrap containers, trays, cassettes & other accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070765	000
K071087	000
K090371	000
K092745	000
K140487	000
K160908	000
K172749	000
K183297	000
K183401	000
K222440	000
K231500	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 9 Inch
Width: 4 Inch

Device Record Status

Public Device Record Key: 2fd749d1-c502-4d50-804c-b9c615894666
Public Version Date: October 25, 2023
Public Version Number: 10
DI Record Publish Date: January 17, 2017