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FibriJet SA-3627

by Micromedics, Inc.

FibriJet SA-3627 is an open-surgery adhesive/sealant applicator (FDA Class I; FDA product code KYZ, Syringe, Irrigating (Non Dental)) made by Micromedics, Inc., listed in FDA GUDID since 6 Jun 2022 (UDI-DI 00815634021617), registry data as of 22 Oct 2026.

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00815634021617 UDI-DI Date6 Jun 2022ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
FibriJet
Generic name
Open-surgery adhesive/sealant applicator, dual-channel
Model / reference
SA-3627
Description
Applicator Tip, Dual Cannula Malleable, 20ga. X 1.8” (4.6cm), Ratio 1:1
Primary DI / UDI-DI
00815634021617
FDA product code
KYZ
GMDN term
Open-surgery adhesive/sealant applicator, dual-channel
Device class
Class I
Regulation number
880.6960
GUDID distribution status
In Commercial Distribution

Related devices

Category: Open-surgery adhesive/sealant applicator, dual-channel

Similar devices in this category

Other devices filed under Open-surgery adhesive/sealant applicator, dual-channel.

Other devices from Micromedics, Inc.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)