TOOLS FOR SURGERY, LLC

Address:1339 Stony Brook Rd,Stony Brook,NY,11790,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

Bulb, Inflation, For Endoscope (FCY) (5) Staple, Implantable (GDW) (2) Dilator, Rectal (FFP) (1)

Premarket Exempt

No Yes

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Anastomosis Leak Tester-OP EX - 00860002701318 Catalog Number : ALT-30EX

Device Description : Expedite and standardize the 'bubble test' for colorectal anastomoses. Includes Expedite and standardize the 'bubble test' for colorectal anastomoses. Includes 3 extender tips.

Device Class : 1

Duns Number: 841842441

Premarket Exempt : Yes

Product Code : FCY

Prescription Use : Yes

Device Count : 1

Anastomosis Leak Tester-LP EX - 00860002701332 Catalog Number : ALT-50EX

Device Description : Expedite and standardize the 'bubble test' for colorectal anastomoses. Includes Expedite and standardize the 'bubble test' for colorectal anastomoses. Includes 3 extender tips.

Device Class : 1

Duns Number: 841842441

Premarket Exempt : Yes

Product Code : FCY

Prescription Use : Yes

Device Count : 1

Hemorrhage Occluder Pin - 00861838000309 Catalog Number : HOP-03

Device Description : Sterile titanium thumbtack designed to control severe sacral bleeding during pel Sterile titanium thumbtack designed to control severe sacral bleeding during pelvic surgery.

Device Class : 2

Duns Number: 841842441

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 1

Hemorrhage Occluder Pin with Applicator - 00861838000316 Catalog Number : HOP-AP

Device Description : Sterile titanium thumbtack designed to control severe sacral bleeding during pel Sterile titanium thumbtack designed to control severe sacral bleeding during pelvic surgery. Also available with applicator.

Device Class : 2

Duns Number: 841842441

Premarket Exempt : No

Product Code : GDW

Prescription Use : Yes

Device Count : 1

Sohn's Dilators - 00861838000323 Catalog Number : SOD-03

Device Description : Dilators used for the treatment of anal fissure.

Device Class : 1

Duns Number: 841842441

Premarket Exempt : Yes

Product Code : FFP

Prescription Use : No

Device Count : 1

Anastomosis Leak Tester-OP - 00861838000354 Catalog Number : ALT-30

Device Description : Expedite and standardize the 'bubble test' for colorectal anastomoses.

Device Class : 1

Duns Number: 841842441

Premarket Exempt : Yes

Product Code : FCY

Prescription Use : Yes

Device Count : 1

Anastomosis Leak Tester-LP - 00861838000361 Catalog Number : ALT-50

Device Description : Expedite and standardize the 'bubble test' for colorectal anastomoses.

Device Class : 1

Duns Number: 841842441

Premarket Exempt : Yes

Product Code : FCY

Prescription Use : Yes

Device Count : 1

Bariatric Anastomosis Leak Tester - 00861838000378 Catalog Number : ALT-BA

Device Description : Expedite and standardize the 'bubble test' for gastrojejunal anastomoses and sle Expedite and standardize the 'bubble test' for gastrojejunal anastomoses and sleeve gastrectomy.

Device Class : 1

Duns Number: 841842441

Premarket Exempt : Yes

Product Code : FCY

Prescription Use : Yes

Device Count : 1

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