AccessGUDID - DEVICE: VERIFY (00724995002534)

GUDID

Device Identifier (DI) Information

Brand Name: VERIFY
Version or Model: PCC070
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: PCC070
Company Name: STERIS CORPORATION

Primary DI Number: 00724995002534
Issuing Agency: GS1
Commercial Distribution End Date: February 07, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 961394798 *Terms of Use

Device Description: The VERIFY VH202 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change. It can be changed in all V-PRO Low Temperature Sterilization Systems and Sterrad 100S, NX 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?
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 [?]
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: Keep dry and away from sunlight. Do not store near heat, moisture, oxidizing agents, acids/alkalis, or cleaning/disinfecting agents.
Storage Environment Temperature: between 16 and 24 Degrees Celsius
Storage Environment Humidity: between 30 and 60 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 60 Yard

Device Record Status

Public Device Record Key: f977139f-7942-4f39-aa35-c04137888fc3
Public Version Date: February 07, 2020
Public Version Number: 6
DI Record Publish Date: December 07, 2016