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Silicone Foam Sacral Dressing with Adhesive Border 46-977

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 Number06937935319058 UDI-DI Date29 Oct 2025ListedStatusListed 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  • Withdrawn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
Silicone Foam Sacral Dressing with Adhesive Border
Generic Name
Exudate-absorbent dressing, non-gel, non-antimicrobial
Model / Reference
46-977
Primary DI / UDI-DI
06937935319058
FDA Product Code
NAD
GMDN Term
Exudate-absorbent dressing, non-gel, non-antimicrobial
Device Class
Class I
Regulation Number
878.4020
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