AccessGUDID - DEVICE: Rovers® EndoCervex-Brush®-S (18719189246299)

GUDID

Device Identifier (DI) Information

Brand Name: Rovers® EndoCervex-Brush®-S
Version or Model: 380100745
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Rovers Medical Devices B.V.

Primary DI Number: 18719189246299
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 402155084 *Terms of Use

Device Description: The EndoCervex-Brush®-S is a single-use cell sampler Intended to collect endocervical cells in women.

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):	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?
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 [?]
K001119	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: eb2e76e8-9fe5-41a6-81f0-243562069ef1
Public Version Date: July 20, 2023
Public Version Number: 1
DI Record Publish Date: July 12, 2023