AccessGUDID - DEVICE: Rovers® Orcellex® Brush RT (08719189246162)

GUDID

Device Identifier (DI) Information

Brand Name: Rovers® Orcellex® Brush RT
Version or Model: 380380331
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Rovers Medical Devices B.V.

Primary DI Number: 08719189246162
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 402155084 *Terms of Use

Device Description: Oral cell sampler, sterile

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
GEE	Brush, Biopsy, General & Plastic Surgery

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: 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: 890acc74-cbd2-4c69-a45b-cf91d8e43a9e
Public Version Date: July 13, 2023
Public Version Number: 3
DI Record Publish Date: October 22, 2017