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Borage Medical Regular

by Suzhou Borage Medical Technology Co., Ltd. 4 variants

Listed FDA GUDID listing, no authorization on record

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 Number06972465050002 UDI-DI Date10 Oct 2026ListedStatusListed GUDID: 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  • Withdrawn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
Borage Medical
Generic Name
Menstrual tampon, unscented
Model / Reference
Regular
Primary DI / UDI-DI
06972465050002
510(k) Number
FDA Product Code
HEB
GMDN Term
Menstrual tampon, unscented
Device Class
Class II
Regulation Number
884.5470
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K090819)

Other devices from Suzhou Borage Medical Technology Co., Ltd.

Properties

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

Other properties (10)

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