S.D.I. USA, INC.

S.D.I. USA, INC.

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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

Needle, Hypodermic, Single Lumen (FMI) (10)

Premarket Exempt

No Yes

Clear

Comfort EZ - 00850002860023 Catalog Number : 50002-0860-02

Device Description : Insulin Pen Needle

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860030 Catalog Number : 50002-0860-03

Device Description : Insulin Pen Needle

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860047 Catalog Number : 50002-0860-04

Device Description : Insulin Pen Needle

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860054 Catalog Number : 50002-0860-05

Device Description : Insulin Pen Needle

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860061 Catalog Number : 50002-0860-06

Device Description : Insulin Pen Needle

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860078 Catalog Number : 50002-0860-07

Device Description : Insulin Pen Needle

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860085 Catalog Number : 50002-0860-08

Device Description : Insulin Pen Needle

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860092 Catalog Number : 50002-0860-09

Device Description : Insulin Pen Needle

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860108 Catalog Number : 50002-0860-10

Device Description : Insulin Pen Needle

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860115 Catalog Number : 50002-0860-11

Device Description : Insulin Pen Needle

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

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