GERI-GENTLE CORPORATION

Address:5 Hollywood Ct,South Plainfield,NJ,07080,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

Polymer Patient Examination Glove (LZA) (4) Needle, Hypodermic, Single Lumen (FMI) (3) Drape, Surgical, Exempt (PUI) (1) Filter, Bacterial, Breathing-Circuit (CAH) (1) Syringe, Piston (FMF) (1)

Premarket Exempt

No Yes

Clear

Gloves - 00369771001426 Catalog Number :

Device Description : GLOVES NITRILE PF MD

Device Class :

Duns Number: 361663839

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

Gloves - 00369771001440 Catalog Number :

Device Description : GLOVES NITRILE PF XL

Device Class :

Duns Number: 361663839

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

Gloves - 00369771001464 Catalog Number :

Device Description : GLOVES NITRILE PF SM

Device Class :

Duns Number: 361663839

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

Gloves - 00369771001488 Catalog Number :

Device Description : GLOVES NITRILE PF LG

Device Class :

Duns Number: 361663839

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

HMEF w/ Flextube - 00369771001525 Catalog Number :

Device Description : HMEF w/ Flextube

Device Class : 2

Duns Number: 361663839

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 30

Syringe 3ml - 00369771001785 Catalog Number :

Device Description : Syringe 3ml

Device Class : 2

Duns Number: 361663839

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 1

NEEDLES 23x1 - 00369771001815 Catalog Number :

Device Description : NEEDLES 23x1

Device Class : 2

Duns Number: 361663839

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

NEEDLES 25x1 - 00369771001846 Catalog Number :

Device Description : NEEDLES 25x1

Device Class : 2

Duns Number: 361663839

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

NEEDLES 25x5/8 - 00369771001877 Catalog Number :

Device Description : NEEDLES 25x5/8

Device Class : 2

Duns Number: 361663839

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 1

Sterile Drape - 00369771002225 Catalog Number :

Device Description : Sterile Drape

Device Class :

Duns Number: 361663839

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 1

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