JUSTRIGHT SURGICAL, LLC

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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) (6) Laparoscope, general & plastic surgery (GCJ) (2) STAPLE, IMPLANTABLE (GDW) (2) STAPLER, SURGICAL (GAG) (2)

Premarket Exempt

Clear

JustRight 5mm Retrieval bag, 60ml - 00850346007009 Catalog Number : JR-60 ECO-10

Device Description : JustRight 5mm Retrieval bag, 60ml, 10 bags/case

Device Class : 2

Duns Number: 025214641

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

JustRight 5mm Retrieval bag, 125ml - 00850346007016 Catalog Number : JR-125 ECO-10

Device Description : JustRight 5mm Retrieval bag, 125ml, 10 bags/case

Device Class : 2

Duns Number: 025214641

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

CoolSeal™ Generator - 00850346007023 Catalog Number : CSL-200-50

Device Description : Electrosurgical Generator

Device Class : 2

Duns Number: 025214641

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

CoolSeal™ Trinity - 00850346007030 Catalog Number : CSL-TR105-30

Device Description : Maryland Laparoscopic Sealer/Divider/Dissector, 30 cm

Device Class : 2

Duns Number: 025214641

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

CoolSeal™ Trinity - 00850346007047 Catalog Number : CSL-TR105-37

Device Description : Maryland Laparoscopic Sealer/Divider/Dissector, 37 cm

Device Class : 2

Duns Number: 025214641

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

CoolSeal™ Trinity - 00850346007061 Catalog Number : CSL-TR105-44

Device Description : Maryland Laparoscopic Sealer/Divider/Dissector, 44 cm

Device Class : 2

Duns Number: 025214641

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

CoolSeal™ Mini - 00850346007085 Catalog Number : CSL-MN103-20

Device Description : Maryland Laparoscopic Sealer

Device Class :

Duns Number: 025214641

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

CoolSeal™ Reveal - 00850346007092 Catalog Number : CSL-RV105-10

Device Description : Open Seal, Divider, and Dissector

Device Class : 2

Duns Number: 025214641

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

JustRight 5mm Stapler - 00865163000102 Catalog Number : JR-ST25-2.0

Device Description : JustRight 5mm Stapler-single

Device Class : 2

Duns Number: 025214641

Premarket Exempt : No

Product Code : GAG, GDW

Prescription Use : Yes

Device Count : 1

JustRight5mm Reload - 00865163000119 Catalog Number : JR-REL25-2.0

Device Description : JustRight 5mm Reload - single

Device Class : 2

Duns Number: 025214641

Premarket Exempt : No

Product Code : GDW, GAG

Prescription Use : Yes

Device Count : 1

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