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Flow Regulator FR-6065

by Covidien LP

Flow Regulator FR-6065 is an open-surgery adhesive/sealant applicator (FDA Class I; FDA product code CAN, Regulator, Pressure, Gas Cylinder) made by Covidien LP, listed in FDA GUDID since 19 Aug 2018 (UDI-DI 10884521057173), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884521057173 UDI-DI Date19 Aug 2018ListedStatusListed 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  • Withdrawn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
Flow Regulator
Generic name
Open-surgery adhesive/sealant applicator, dual-channel
Model / reference
FR-6065
Primary DI / UDI-DI
10884521057173
FDA product code
CAN
GMDN term
Open-surgery adhesive/sealant applicator, dual-channel
Device class
Class I
Regulation number
868.2700
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 Covidien LP

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    Class II

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    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)