DEVICE: Rovers® Cervex-Brush® (08719189246025)

Device Identifier (DI) Information

Rovers® Cervex-Brush®
380100324
In Commercial Distribution

Rovers Medical Devices B.V.
08719189246025
GS1

25
402155084 *Terms of Use
Cervical cell sampler
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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
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FDA Product Code

[?]
Product Code Product Code Name
HHT Spatula, Cervical, Cytological
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K930955 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

eb7dfc5e-0a61-466e-ba2e-01f065117072
August 08, 2018
1
July 08, 2018
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 08719189246049 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+31412648870
info@roversmedicaldevices.com
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