AccessGUDID - DEVICE: Rovers® Cervex-Brush® (87191892460016)

GUDID

Device Identifier (DI) Information

Brand Name: Rovers® Cervex-Brush®
Version or Model: 380100311
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Rovers Medical Devices B.V.

Primary DI Number: 87191892460016
Issuing Agency: GS1
Commercial Distribution End Date: August 01, 2018
Device Count: 50
Labeler D-U-N-S® Number*: 402155084 *Terms of Use

Device Description: Cervical cell sampler

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):	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?
42537	Cytology scraper, single-use	A wooden, plastic, or metal instrument used to collect a scraping of cells from tissue for the purposes of a diagnostic examination. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HHT	Spatula, Cervical, Cytological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K930955	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: 3966bb23-94be-4c1c-90b1-159b76bbc4d1
Public Version Date: September 12, 2019
Public Version Number: 4
DI Record Publish Date: October 03, 2016