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Stratus Pharmaceuticals, Inc. 960-31

by Stratus Pharmaceuticals, 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 Number00358980960310 UDI-DI Date10 Nov 2025ListedStatusListed 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  • Withdrawn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

Trade Name
Stratus Pharmaceuticals, Inc.
Generic Name
Skin semi-occlusive dressing, non-antimicrobial
Model / Reference
960-31
Primary DI / UDI-DI
00358980960310
510(k) Number
FDA Product Code
FRO
GMDN Term
Skin semi-occlusive dressing, non-antimicrobial
Device Class
U
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K110172)

Other devices from Stratus Pharmaceuticals, Inc.

Properties

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

Other properties (9)

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