AccessGUDID - DEVICE: NA (10724995044234)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 410100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 410100
Company Name: STERIS CORPORATION

Primary DI Number: 10724995044234
Issuing Agency: GS1
Commercial Distribution End Date: April 08, 2020
Device Count: 9
Labeler D-U-N-S® Number*: 961394798 *Terms of Use

Device Description: The VERIFY General Purpose EO Process Indicator Tape adheres to both natural and synthetic materials commonly used in sterile processing. They are used to identify processed packs from unprocessed packs.

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):	Yes
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?
44427	Sterilization packaging tape	A non-sterile, flexible, band (typically made of paper) coated on one side with a pressure-sensitive adhesive, used to seal packages of instruments, utensils, or medical devices that are wrapped in drapes or sterilization packaging, prior to being sterilized in the hospital or other facility. This device will typically have indicators on its non-adhesive side that darken to indicate that the package has been sterilized. It typically comes in rolls in a variety of widths. After application, this device cannot be reused.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JOJ	Indicator, physical/chemical sterilization process

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K890760	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: Controlled Room Temperature
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 60 Yard
Width: 1 Inch

Device Record Status

Public Device Record Key: 745841b2-7450-44ab-99da-28101b2d3ee1
Public Version Date: April 08, 2020
Public Version Number: 6
DI Record Publish Date: September 09, 2016