AMITY HOLDINGS, LLC

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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

Lancet, Blood (FMK) (7) Needle, Hypodermic, Single Lumen (FMI) (3)

Premarket Exempt

No Yes

Clear

ReadyLance - 00732671008039 Catalog Number : 803

Device Description : Safety Lancet

Device Class :

Duns Number: 016069284

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

ReadyLance - 00732671008053 Catalog Number : 805

Device Description : Safety Lancet

Device Class :

Duns Number: 016069284

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

ReadyLance - 00732671008060 Catalog Number : 806

Device Description : Safety Lancet

Device Class :

Duns Number: 016069284

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

ReadyLance - 00732671008077 Catalog Number : 807

Device Description : Safety Lancet

Device Class :

Duns Number: 016069284

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

ReadyLance - 00732671008084 Catalog Number : 808

Device Description : Safety Lancet

Device Class :

Duns Number: 016069284

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

PIP - 00732671009319 Catalog Number : 931

Device Description : Insulin Pen Needle 32ga X 4.0mm

Device Class : 2

Duns Number: 016069284

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

PIP - 00732671009326 Catalog Number : 932

Device Description : Insulin Pen Needle 31ga X 5.0mm

Device Class : 2

Duns Number: 016069284

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

PIP - 00732671009333 Catalog Number : 933

Device Description : Insulin Pen Needle 31ga X 6.0mm

Device Class : 2

Duns Number: 016069284

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

PIP - 00732671009340 Catalog Number : 934

Device Description : 33ga Twist Lancets

Device Class : 2

Duns Number: 016069284

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

PIP - 00732671009357 Catalog Number : 935

Device Description : Lancing Device with Ejector

Device Class :

Duns Number: 016069284

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

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