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ExtriCARE ST390-0002

by Alleva Medical, Ltd.

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 Number04897089070088 UDI-DI Date5 Mar 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  • Withdrawn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
ExtriCARE
Generic Name
Negative-pressure wound therapy system dressing set
Model / Ref / Catalog
ST390-0002, EC2400-MN-E
Primary DI / UDI-DI
04897089070088
FDA Product Code
OMP
GMDN Term
Negative-pressure wound therapy system dressing set
Device Class
Class II
Regulation Number
878.4780
GUDID distribution status
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Other devices from Alleva Medical, Ltd.

See all devices from Alleva Medical, Ltd. →

Properties

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

Other properties (8)

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