AccessGUDID - DEVICE: Rovers® Cervex-Brush® (08719189246483)

GUDID

Device Identifier (DI) Information

Brand Name: Rovers® Cervex-Brush®
Version or Model: 491461
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Rovers Medical Devices B.V.

Primary DI Number: 08719189246483
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
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: b3dc1f2c-673e-4d13-8dc2-da6f7e0a678a
Public Version Date: September 12, 2019
Public Version Number: 2
DI Record Publish Date: July 09, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
18719189246480	20	08719189246483		In Commercial Distribution	Box
28719189246487	176	18719189246480		In Commercial Distribution	Export Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 08719189246049 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +31412648870
Email: info@roversmedicaldevices.com

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