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FlexFire Universal Handpiece 100016

by Gi Windows

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 Number00860012315512 UDI-DI Date27 Jan 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  • Withdrawn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
FlexFire Universal Handpiece
Generic Name
Gastrointestinal anastomosis coupler, non-bioabsorbable
Model / Ref / Catalog
100016, FFU-DLT-1
Primary DI / UDI-DI
00860012315512
FDA Product Code
SAH
GMDN Term
Gastrointestinal anastomosis coupler, non-bioabsorbable
Device Class
Class II
Regulation Number
878.4816
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Other devices from Gi Windows

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Properties

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

Other properties (7)

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