AccessGUDID - DEVICE: Pro-Lite (00724995002947)

GUDID

Device Identifier (DI) Information

Brand Name: Pro-Lite
Version or Model: VP0071
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VP0071
Company Name: STERIS CORPORATION

Primary DI Number: 00724995002947
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961394798 *Terms of Use

Device Description: The PRO-Lite Sterilization Tray Mat, 13-inch x 4.5-inch, is used in V-PRO Low Temperature Sterilization Systems.

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:	No
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?
34004	Surgical instrument guard, reusable	A device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable 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 [?]
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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 5 Inch
Length: 13 Inch

Device Record Status

Public Device Record Key: 2a6b69cf-a6a3-46d5-82d2-e16643d62f14
Public Version Date: October 21, 2024
Public Version Number: 8
DI Record Publish Date: February 01, 2018