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Sacral Silicone Superabsorbent Dressing GEN-19690

by Shanghai Iso Medical Products Co., 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06937935316927 UDI-DI Date3 Aug 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  • Withdrawn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
Sacral Silicone Superabsorbent Dressing
Generic Name
Wound-nonadherent dressing, absorbent, non-antimicrobial
Model / Reference
GEN-19690
Primary DI / UDI-DI
06937935316927
FDA Product Code
NAC
GMDN Term
Wound-nonadherent dressing, absorbent, non-antimicrobial
Device Class
Class I
Regulation Number
878.4018
GUDID distribution status
In Commercial Distribution

Other devices from Shanghai Iso Medical Products Co., Ltd.

See all devices from Shanghai Iso Medical Products Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

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