GSOURCE LLC

Address:19 Bland St,EMERSON,NJ,07630,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

Pin, Fixation, Smooth (HTY) (3) Burr, Orthopedic (HTT) (2) Cutter, Wire (HXZ) (2) Orthopedic Manual Surgical Instrument (LXH) (2) Plier, Orthodontic (JEX) (1)

Premarket Exempt

No Yes

Clear

gSource - M7557923160 Catalog Number : gS 79.2316

Device Description : K-Wire D. Trocar 6" 1.6mm [.062"] Ti Alloy pkg/1

Device Class : 2

Duns Number: 008162518

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

gSource - M7557923161 Catalog Number : gS 79.2318

Device Description : K-Wire D. Trocar 6" 1.8mm [.070"] Ti Alloy pkg/1

Device Class : 2

Duns Number: 008162518

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

gSource - M7557923181 Catalog Number : gS 79.2316

Device Description : K-Wire D. Trocar 6" 1.6mm [.062"] Ti Alloy pkg/1

Device Class : 2

Duns Number: 008162518

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

gSource - M7558060180 Catalog Number : gS 80.6018

Device Description : Bur, Diamond 1 3/4", Ø 1.8mm cone tapered w/flat top, medium, max rpm 40,000, ss shank

Device Class : 1

Duns Number: 008162518

Premarket Exempt : Yes

Product Code : HTT

Prescription Use : No

Device Count : 1

gSource - M7558063550 Catalog Number : gS 80.6355

Device Description : Bur, Diamond 1 3/4", Ø 4.5mm bud, medium, max rpm 30,000, ss shank

Device Class : 1

Duns Number: 008162518

Premarket Exempt : Yes

Product Code : HTT

Prescription Use : No

Device Count : 1

gSource - M7558170950 Catalog Number : gS 81.7095

Device Description : Locking Pliers 8" medium

Device Class : 1

Duns Number: 008162518

Premarket Exempt : Yes

Product Code : JEX

Prescription Use : No

Device Count : 1

gSource - M7558202920 Catalog Number : gS 82.0292

Device Description : Plate Bending Press 16" table top for plates up to 4.5mm [.177"]

Device Class : 1

Duns Number: 008162518

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

gSource - M7558247400 Catalog Number : gS 82.4740

Device Description : Steinmann Pin Chuck 4", w/key, max ID 7.0mm chuck, 5.0mm cann

Device Class : 1

Duns Number: 008162518

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

gSource - M7558372280 Catalog Number : gS 83.7228

Device Description : Wire Cutter DA 6 1/2", angled, TC, max cap 1.6mm [.062"]

Device Class : 1

Duns Number: 008162518

Premarket Exempt : Yes

Product Code : HXZ

Prescription Use : No

Device Count : 1

gSource - M7558375130 Catalog Number : gS 83.7513

Device Description : End Cutter DA 6", TC, max cap 1.6mm [.062"]

Device Class : 1

Duns Number: 008162518

Premarket Exempt : Yes

Product Code : HXZ

Prescription Use : No

Device Count : 1

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