OPUS KSD, INC.

Address:50 Corporate Park Drive,East Pembroke,MA,02359,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Staple, Implantable (GDW) (2) Stapler, Surgical (GAG) (2)

Premarket Exempt

Clear

SubQ It! - 00867469000206 Catalog Number :

Device Description : SubQ It! Bioabsorbable Skin Closure System consists of a single-patient use, dis SubQ It! Bioabsorbable Skin Closure System consists of a single-patient use, disposable stapler preloaded with 10 bioabsorbable fasteners, packaged and sterilized individually in a protective foil pouch.

Device Class :

Duns Number: 965571289

Premarket Exempt : No

Product Code : GDW, GAG

Prescription Use : Yes

Device Count : 1

SubQ It! - 00867469000213 Catalog Number : 408010

Device Description : SubQ It! Bioabsorbable Skin Closure SF10 is a single-patient use, skin stapler p 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.

Device Class : 2

Duns Number: 965571289

Premarket Exempt : No

Product Code : GDW, GAG

Prescription Use : Yes

Device Count : 1

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