AccessGUDID - DEVICE: VENTANA HE 600 Coverslip Activator (04015630967117)

GUDID

Device Identifier (DI) Information

Brand Name: VENTANA HE 600 Coverslip Activator
Version or Model: 07534396001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 07534396001
Company Name: Ventana Medical Systems, Inc.

Primary DI Number: 04015630967117
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?
59122	Xylene solution substitute IVD	A xylene substitute solution which may include d-limonene and/or hydrocarbon-based solutions, intended to be used alone or in combination with other IVDs in the processing, staining and/or testing of clinical laboratory specimens.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General purpose reagent

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: 05aa31e3-c4ce-43e9-b3cd-db555c058d08
Public Version Date: June 18, 2021
Public Version Number: 2
DI Record Publish Date: February 03, 2021