Opus KSD, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30113011033011301103Opus KSD, Inc.1N2026-01-0150 Corporate Park Drive Suite 710 East Pembroke MA US 02359

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00867469000213SubQ It! - SubQ It! Bioabsorbable Skin Closure SF10 is a single-patient use, skin stapler preloaded with 10 bioabsorbable fasteners, packaged and sterilized individually in a protective foil pouch.3399338811rob@subq-it.com
00867469000220SubQ It! Bioabsorbable Skin Closure System - SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.3399338811rob@subq-it.com
00867469000237SubQ It! Bioabsorbable Skin Closure System - SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.3399338811chuck@subq-it.com
00867469000244SubQ It! Bioabsorbable Skin Closure System - SubQ It! Bioabsorbable Driver SU-25 is a single-patient use, skin closure device, preloaded with 25 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.3399338811chuck@subq-it.com
10867469000210SubQ It! - SubQ It! Bioabsorbable Skin Closure SF10 is a single-patient use, skin stapler preloaded with 10 bioabsorbable fasteners, packaged and sterilized individually in a protective foil pouch.3399338811rob@subq-it.com
10867469000227SubQ It! Bioabsorbable Skin Closure System - SubQ It! Bioabsorbable Driver SU-10 is a single-patient use, skin closure device, preloaded with 10 bioabsorbable dermal fasteners, packaged sterile in a protective foil pouch.3399338811rob@subq-it.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1767751775703175K131563SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEMGDW2014-04-09

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GDW22014-04-09

PMN#

GUDID#