Consulting Wallah › Device Explorer › Other devices › Open-surgery adhesive/sealant applicator, dual-cha
Device Explorer · FDA GUDID · GMDN 44830

Open-surgery adhesive/sealant applicator, dual-channel

A sterile dual-channel delivery device designed to enable a surgeon to apply with precision a two-component medication or adhesive/sealant to a surgical site during open surgery (e.g., arterial anastomosis, colonic anastomosis, and vascular graft reconstructio

US‑registered devices124in commercial distribution
Companies7labelers on GUDID
Single‑use99%of device records
Sterile99%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Micromedics, Inc.9677%
Baxter Healthcare Corporation97%
Artivion, Inc.76%
Integra Lifesciences Corporation54%
Biomet Biologics, Llc32%
Baxter International Inc.32%
Covidien Lp11%

Top labelers

CompanyDevicesShare
Micromedics, Inc.9677%
Baxter Healthcare Corporation97%
Artivion, Inc.76%
Integra Lifesciences Corporation54%
Biomet Biologics, Llc32%
Baxter International Inc.32%
Covidien Lp11%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PREVELEAK SURGICAL SEALANTTISSEEL/ARTISS SPRAY SETCOSEAL SPRAY SETBiomet® BiologicsBIOMET® BIOLOGICSBiomet®BioGlue Surgical AdhesiveFibriJetPramandDISCSEELNordson MedicalFIBRIJETGasless TipACTAMAXLife SpineCelling Biosciences Versatile Delivery Kit

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KYZSyringe, Irrigating (Non Dental)50
FMFSyringe, Piston36
GCJLaparoscope, General & Plastic Surgery23
FMFSyringe, piston19
MUQGlue, Surgical, Arteries7
MUQGlue,Surgical,Arteries7

GMDN & GCC registration

  • GMDN code 44830 · non‑implantable
  • Single‑use 99% · sterile 99% · Rx‑only 98% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Centimeter) · 23Total Volume (Milliliter) · 3Length (Millimeter) · 2Height (Centimeter) · 1

Use these as the dimensions to specify in a tender line.

How many open-surgery adhesive/sealant applicator, dual-channel products are registered in the US?

124 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Open-surgery adhesive/sealant applicator, dual-channel", from 7 companies. The largest labeler is Micromedics, Inc. with 77% of records.

Which FDA product codes apply?

KYZ (Syringe, Irrigating (Non Dental)), FMF (Syringe, Piston), GCJ (Laparoscope, General & Plastic Surgery), FMF (Syringe, piston)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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