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Hilo S4005

by Hilo Enterprises LLC 2 variants

Listed FDA GUDID listing, not in commercial distribution

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 Number00860008076595 UDI-DI Date4 Jan 2022ListedStatusListed GUDID: not 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  • Withdrawn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
Hilo
Generic Name
Surgical gown, single-use
Model / Reference
S4005
Primary DI / UDI-DI
00860008076595
FDA Product Code
FYA
GMDN Term
Surgical gown, single-use
Device Class
Class II
Regulation Number
878.4040
GUDID distribution status
Not in Commercial Distribution

Properties

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

Other properties (10)

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