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GluStitch Inc.

Canada·CA-MF-000006943

Last updated September 18, 2026

About

GluStitch has a Quality Management System certified as being in conformity with ISO 13485:2016 by Intertek. GluStitch's wound management products contain octyl and butyl cyanoacrylate adhesives which are blended together to make ideal formulations for our customers' specific uses.GluStitch Inc. manufactures three products that are made available to the dental and medical markets; PeriAcryl® Oral Liquid Dressing, GluStitch® Topical Tissue Adhesive, and GluSeal® Liquid Bandage.

From the manufacturer's own website. Source

Information

Country
Canada
Address
7188, Progress Way, Delta, Canada
LinkedIn
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Facebook
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Phone
1-877-940-2262
PRRC Contact
James Sisler
EUDAMED SRN
CA-MF-000006943
FDA FEI Number
—
DUNS Number
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Catalogue (8)

DeviceModel / ReferenceRegistriesClassStatus
PeriAcryl®90 P-ACRYL5(V)CEHV
EUDAMEDFDA UDI
Class IActive
Gluseal 5ml Dispenser, 1 Ml Dispenser, .2 Ml Dispenser K030574
FDA 510(k)
Class IActive
GluStitch Twist Tissue Adhesive K150032
FDA 510(k)
Class IIActive
Glusite, Model Glu002 K013446
FDA 510(k)
Class IIActive
Periacryl 90, 80, 70, 60, Model9010, 8020, 7030, 6040 K071484
FDA 510(k)
Class IIActive
Gluseal 90, Model Glu9010 K083752
FDA 510(k)
Class IActive
PeriAcryl®90 P-ACRYL2(V)HV
EUDAMEDFDA UDI
Class IActive
PeriAcryl®90 HV Cyanoacrylate Oral Adhesive P-ACRYL(V)HVCE
EUDAMEDFDA UDI
Class IActive

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