GI Supply, Inc.

Address:5069 Ritter Road,Mechanicsburg,PA,17055,US

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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

General Surgery Tray (LRO) (4) Marker,Colon (NBG) (2) General Surgery Tray (Kit) (LRO) (1) Pump, Portable, Aspiration (Manual Or Powered) (BTA) (1) Submucosal Injection Agent (PLL) (1) Test, Glycosylated Hemoglobin, Over The Counter (NGB) (1)

Premarket Exempt

No Yes

Clear

Large Volume Paracentesis Kit - 00893029002007 Catalog Number : GIS-28

Device Description : The GI Supply Large Volume Paracentesis Kit

Device Class : 2

Duns Number: 160990313

Premarket Exempt : No

Product Code : LRO

Prescription Use : Yes

Device Count : 1

SPOT Endosopic Marker - 00893029002069 Catalog Number : GIs-44

Device Class : 2

Duns Number: 160990313

Premarket Exempt : Yes

Product Code : NBG

Prescription Use : Yes

Device Count : 1

RenovaRP Paracentesis Pump - 00893029002076 Catalog Number : GIS-27

Device Description : The GI Supply Paracentesis Pump is intended as a suction pump to remove ascitic

Device Class : 2

Duns Number: 160990313

Premarket Exempt : No

Product Code : BTA

Prescription Use : Yes

Device Count : 1

Spot Ex Endoscopic Tattoo - 00893029002106 Catalog Number : GIS-45

Device Class : 2

Duns Number: 160990313

Premarket Exempt : Yes

Product Code : NBG

Prescription Use : Yes

Device Count : 1

RenovaRP Fluid Drainage Bag - 00893029002151 Catalog Number : GIS-29

Device Description : RenovaRP Fluid Drainage Bag to be used with RenovaRP Paracentesis Pump - sold in box of 20

Device Class :

Duns Number: 160990313

Premarket Exempt : No

Product Code : LRO

Prescription Use : No

Device Count : 1

RenovaRP Tube Set - 00893029002168 Catalog Number : GIS-30

Device Description : RenovaRP Tube Set from GI Supply is intended to be used in conjunction with the

Device Class : 2

Duns Number: 160990313

Premarket Exempt : No

Product Code : LRO

Prescription Use : Yes

Device Count : 1

RenovaRP Paracentesis Kit - 00893029002175 Catalog Number : GIS-32

Device Description : Large Volume Paracentesis Kit. The GI Supply RenovaRP Paracentesis Kit is intend

Device Class :

Duns Number: 160990313

Premarket Exempt : No

Product Code : LRO

Prescription Use : No

Device Count : 1

Spot Ex CE Endoscopic Tattoo - 00893029002199 Catalog Number : GIS-46S

Device Description : Spot Ex is indicated for endoscopically tattooing lesions in the GI tract for up

Device Class : 2

Duns Number: 160990313

Premarket Exempt : Yes

Product Code : NGB

Prescription Use : No

Device Count : 1

EverLift - 00893029002229 Catalog Number : GIS-55

Device Description : Submucosal Lifting Agent - 5mL Single Unit

Device Class :

Duns Number: 160990313

Premarket Exempt : No

Product Code : PLL

Prescription Use : Yes

Device Count : 1

RenovaRP Kit No Catheter - 00893029002236 Catalog Number : GIS-31

Device Description : The GI Supply RenovaRP Paracentesis Kit is intended to be used in conjunction wi

Device Class : 2

Duns Number: 160990313

Premarket Exempt : No

Product Code : LRO

Prescription Use : No

Device Count : 1

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