AccessGUDID - DEVICE: NA (00724995152369)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 881121
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 881121
Company Name: STERIS CORPORATION

Primary DI Number: 00724995152369
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961394798 *Terms of Use

Device Description: The Vis-U-All High Temperature Sterilization Tubing, 12 inch x 100 feet are validated for use with ethylene oxide and steam sterilization.

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
JOJ	Indicator, physical/chemical sterilization process

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 in a cool and dry environment. Avoid direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
Length: 100 Feet
Width: 12 Inch

Device Record Status

Public Device Record Key: 539ba80e-aa6e-4f5e-bdd1-260f4fbdcb33
Public Version Date: January 28, 2025
Public Version Number: 7
DI Record Publish Date: January 27, 2017