NASHVILLE SURGICAL INSTRUMENTS, LLC

Address:2005 KUMAR LANE,Springfield,TN,37172,US

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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

Catheter, Cholangiography (GBZ) (3) Staple, Implantable (GDW) (1) Suture, Nonabsorbable, Synthetic, Polyamide (GAR) (1)

Premarket Exempt

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Kumar Catheter® - B361CC0190 Catalog Number : CC-019

Device Description : The Kumar Catheter®, used in conjunction with Kumar Cholangiography® Clamp, is m The Kumar Catheter®, used in conjunction with Kumar Cholangiography® Clamp, is meant to provide a means of laparoscopic cholangiography. It comprises a translucent tubing ( 76 cm. length and 16 ga. ) that carries a 19 ga., 1.25 cm long needle at the end. The Kumar Catheter® is used to puncture the Hartmann's pouch of the gallbladder for biliary access and / or aspiration. Product is latex free.

Device Class :

Duns Number: 030096122

Premarket Exempt : No

Product Code : GBZ

Prescription Use : Yes

Device Count : 1

Kumar Clamp® - B361KC0020 Catalog Number : KC-002

Device Description : The Kumar Clamp® is a reusable 5mm stainless steel laparoscopic grasper of 37 cm The Kumar Clamp® is a reusable 5mm stainless steel laparoscopic grasper of 37 cm length with long ( 3.8 cm) atraumatic jaws and a channel for introduction of the single use Kumar Catheter®. The system is meant to provide a method of laparoscopic cholangiography.

Device Class : 1

Duns Number: 030096122

Premarket Exempt : No

Product Code : GBZ

Prescription Use : Yes

Device Count : 1

Kumar Clamp® for Single Port, Bariatrics and Robotics - B361KC2XL0 Catalog Number : KC-2XL

Device Description : The Kumar Clamp® for Single Port, Bariatrics and Robotics is a reusable 5mm stai The Kumar Clamp® for Single Port, Bariatrics and Robotics is a reusable 5mm stainless steel laparoscopic grasper of 45 cm length with long ( 3.8 cm) atraumatic jaws and a channel for introduction of the single use Kumar Catheter®. The system is meant to provide a method of laparoscopic cholangiography.

Device Class : 1

Duns Number: 030096122

Premarket Exempt : No

Product Code : GBZ

Prescription Use : Yes

Device Count : 1

Kumar T-ANCHORS® Hernia Set - B361TA0080 Catalog Number : TA-008

Device Description : The Kumar T-ANCHORS® Hernia Set provides a means of Fixation of the Mesh in Lapa The Kumar T-ANCHORS® Hernia Set provides a means of Fixation of the Mesh in Laparoscopic or Open Repair of Abdominal Wall Hernia as Trans-fascial sutures, in addition to the tackers. Kumar T-ANCHORS® eliminate the need for grasping and feeding of sutures into a Suture Passer.

Device Class :

Duns Number: 030096122

Premarket Exempt : No

Product Code : GDW, GAR

Prescription Use : Yes

Device Count : 1

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