AccessGUDID - DEVICE: CINtec Histology (04015630970452)

GUDID

Device Identifier (DI) Information

Brand Name: CINtec Histology
Version or Model: 50 Tests
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06680003001
Company Name: Ventana Medical Systems, Inc.

Primary DI Number: 04015630970452
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):	Yes
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?
57495	p16 antigen IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of p16 antigen in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PRB	Cervical intraepithelial neoplasia (CIN) test system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN160019	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d9a10612-b11a-40aa-8868-b015c3dba075
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: March 29, 2017