ORANGE SURGICAL INSTRUMENTS, LLC

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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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (10)

Premarket Exempt

Clear

Stomach Grasper Inner Shaft - B3543320 Catalog Number : 332

Device Description : Stomach Grasper Inner Shaft

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Fenestrated Grasper Inner Shaft - B3543330 Catalog Number : 333

Device Description : Fenestrated Grasper Inner Shaft

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Mesentary Forcep Inner Shaft - B3543350 Catalog Number : 335

Device Description : Mesentary Forcep Inner Shaft

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Bowel Grasper Inner Shaft - B3543360 Catalog Number : 336

Device Description : Bowel Grasper Inner Shaft

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Dorsey Grasper Inner Shaft - B354337 Catalog Number : 337

Device Description : Dorsey Grasper Inner Shaft

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Allis Grasper Inner Shaft - B354338 Catalog Number : 338

Device Description : Allis Grasper Inner Shaft

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Fenestrated Long Inner Shaft 44cm - B354339B0 Catalog Number : 339B

Device Description : Fenestrated Long Inner Shaft 44cm

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Needle Holder Left Curve - B354343L0 Catalog Number : 343L

Device Description : Needle Holder Left Curve

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Needle Holder Left Curve - B354343R0 Catalog Number : 343R

Device Description : Needle Holder Left Curve

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Needle Holder Straight - B354343S0 Catalog Number : 343S

Device Description : Needle Holder Straight

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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