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Woundigen KIT-0S-S

by Human Brain Wave SRL

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08058481670238 UDI-DI Date24 Sep 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  • Withdrawn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
Woundigen
Generic Name
Dermatome blade, single-use
Model / Reference
KIT-0S-S
Primary DI / UDI-DI
08058481670238
FDA Product Code
FZW
GMDN Term
Dermatome blade, single-use
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution

Other devices from Human Brain Wave SRL

Properties

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

Other properties (7)

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