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

Rat Tooth Forceps (4+2 Teeth) Inner Shaft - B3542720 Catalog Number : 272

Device Description : Rat Tooth Forceps (4+2 Teeth) Inner ShaftRat Tooth Forceps (4+2 Teeth) Inner Shaft

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Alligator Inner Shaft 44cm - B354273B0 Catalog Number : 273B

Device Description : Alligator Inner Shaft 44cm

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Wave Grasper Inner Shaft 44cm - B354274B0 Catalog Number : 274B

Device Description : Wave Grasper Inner Shaft 44cm

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Babcock Inner Shaft 44cm - B354275B0 Catalog Number : 275B

Device Description : Babcock Inner Shaft 44cm

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Debakey Grasper Inner Shaft 44cm - B354276B0 Catalog Number : 276B

Device Description : Debakey Grasper Inner Shaft 44cm

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Duck Bill Forceps Inner Shaft 44cm - B3542770 Catalog Number : 277B

Device Description : Duck Bill Forceps Inner Shaft 44cm

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Fenestrated Atraumatic Forceps Inner Shaft - B354279 Catalog Number : 279

Device Description : Fenestrated Atraumatic Forceps Inner Shaft

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Clinch Grapser Inner Shaft - B3542800 Catalog Number : 280

Device Description : Clinch Grapser Inner Shaft

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Fenestrated Grasper Inner Shaft 44cm - B354281B0 Catalog Number : 281B

Device Description : Fenestrated Grasper Inner Shaft 44cm

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Dolphin Grasper Inner Shaft - B3543310 Catalog Number : 331

Device Description : Dolphin Grasper Inner Shaft

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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