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Na S1001-2020

by Carilex Medical, Inc.

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 Number04713616092906 UDI-DI Date12 Jun 2018ListedStatusListed 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  • Withdrawn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

Generic Name
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Model / Reference
S1001-2020
Primary DI / UDI-DI
04713616092906
510(k) Number
FDA Product Code
OMP
GMDN Term
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Device Class
Class II
Regulation Number
878.4780
GUDID distribution status
In Commercial Distribution

Related devices

Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial

Cleared under the same submission (K172725)

Other devices from Carilex Medical, Inc.

See all devices from Carilex Medical, Inc. →

Properties

  • Sterile
  • Single Use
  • Contains Latex
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

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