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

Biopsy Forceps Inner Shaft - B3541120 Catalog Number : 112

Device Description : Biopsy Forceps Inner Shaft

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Biopsy Forceps with teeth Inner Shaft - B3541130 Catalog Number : 113

Device Description : Biopsy Forceps with teeth Inner Shaft

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Biopsy Punch Inner Shaft - B354115 Catalog Number : 115

Device Description : Biopsy Punch Inner Shaft

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Hook Scissor Inner Shaft 44cm - B354258B0 Catalog Number : 258B

Device Description : Hook Scissor Inner Shaft 44cm

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Straight Dissector Inner Shaft 44cm - B354261B0 Catalog Number : 261B

Device Description : Straight Dissector Inner Shaft 44cm

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Maryland 30 Degree Inner Shaft 44cm - B354262B0 Catalog Number : 262B

Device Description : Maryland 30 Degree Inner Shaft 44cm

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Maryland 45 Degree Inner Shaft 44cm - B354263B0 Catalog Number : 262B

Device Description : Maryland 45 Degree Inner Shaft 44cm

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Maryland 70 Degree Inner Shaft 44cm - B354264B0 Catalog Number : 264B

Device Description : Maryland 70 Degree Inner Shaft 44cm

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Mixter Inner Shaft 44cm - B354265B0 Catalog Number : 265B

Device Description : Mixter Inner Shaft 44cm

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Blunt Nose Inner Shaft 44cm - B354266B0 Catalog Number : 266B

Device Description : Blunt Nose Inner Shaft 44cm

Device Class : 2

Duns Number: 047063695

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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