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Rovers® Cervex-Brush® 490524

by Tripath Imaging, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10382904905245 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Rovers® Cervex-Brush®
Generic Name
Cytology scraper, single-use
Model / Ref / Catalog
490524
Primary DI / UDI-DI
10382904905245
510(k) Number
FDA Product Code
HHT
GMDN Term
Cytology scraper, single-use
Device Class
Class II
Regulation Number
884.4530
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K930955)

Other devices from Tripath Imaging, Inc.

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No