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Compact Wound Seal Kit 04

by Safeguard Us Operating, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 NumberM689HHCWS01040 UDI-DI Date13 Oct 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Compact Wound Seal Kit
Generic Name
Pneumothorax dressing
Model / Ref / Catalog
04, HHCWS01
Primary DI / UDI-DI
M689HHCWS01040
FDA Product Code
NAE
GMDN Term
Pneumothorax dressing
Device Class
Class I
Regulation Number
878.4022
GUDID distribution status
In Commercial Distribution

Other devices from Safeguard Us Operating, LLC

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Properties

  • Sterile
  • Single Use
  • Over-the-Counter
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No