AccessGUDID - DEVICE: PROTEASE 2 (04015630971145)

GUDID

Device Identifier (DI) Information

Brand Name: PROTEASE 2
Version or Model: 05266696001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 05266696001
Company Name: Ventana Medical Systems, Inc.

Primary DI Number: 04015630971145
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184042521 *Terms of Use

Device Description: No description.

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):	No
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?
57778	Immunohistochemistry protease reagent IVD	A substance or reactant which may include proteinase K and/or pepsin intended to be used for the enzymatic retrieval of antigenic epitopes from tissue in an enzyme immunohistochemistry assay performed on biological tissues or clinical specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IBG	TRYPSIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: 2ff0d653-4cce-4ddb-a15e-9ff72937f6e2
Public Version Date: June 18, 2021
Public Version Number: 2
DI Record Publish Date: January 29, 2021