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Curaplex Advanced Hemostatic Gauze 4in x 4in (10cm x 10cm)

by Bound Tree Medical, LLC

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 Number00199972000009 UDI-DI Date17 Dec 2025ListedStatusListed 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  • Withdrawn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
Curaplex Advanced Hemostatic Gauze
Generic Name
Chitosan haemostatic agent, professional, non-bioabsorbable
Model / Ref / Catalog
4in x 4in (10cm x 10cm), CAHG-4X4
Primary DI / UDI-DI
00199972000009
510(k) Number
FDA Product Code
QSY
GMDN Term
Chitosan haemostatic agent, professional, non-bioabsorbable
Device Class
U
GUDID distribution status
In Commercial Distribution
Sterilization Method
Radiation Sterilization

Related devices

Cleared under the same submission (K222909)

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No