DEVICE: Rovers® Cervex-Brush® (08719189246025)
Device Identifier (DI) Information
Rovers® Cervex-Brush®
380100324
In Commercial Distribution
Rovers Medical Devices B.V.
380100324
In Commercial Distribution
Rovers Medical Devices B.V.
Cervical cell sampler
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
eb7dfc5e-0a61-466e-ba2e-01f065117072
August 08, 2018
1
July 08, 2018
August 08, 2018
1
July 08, 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 |
---|---|---|---|---|---|
08719189246032 | 20 | 08719189246025 | In Commercial Distribution | 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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+31412648870
info@roversmedicaldevices.com
info@roversmedicaldevices.com