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

Syringe, Piston (FMF) (10)

Premarket Exempt

No Yes

Clear

Comfort EZ - 00850002860122 Catalog Number : 50002-0860-12

Device Description : Insulin Syringe - 100 count

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860139 Catalog Number : 50002-0860-13

Device Description : Insulin Syringe - 100 count

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860146 Catalog Number : 50002-0860-14

Device Description : Insulin Syringe - 100 count

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860153 Catalog Number : 50002-0860-15

Device Description : Insulin Syringe - 100 count

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860160 Catalog Number : 50002-0860-16

Device Description : Insulin Syringe - 100 count

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860177 Catalog Number : 50002-0860-17

Device Description : Insulin Syringe - 100 count

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860184 Catalog Number : 50002-0860-18

Device Description : Insulin Syringe - 100 count

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860191 Catalog Number : 50002-0860-19

Device Description : Insulin Syringe - 100 count

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860207 Catalog Number : 50002-0860-20

Device Description : Insulin Syringe - 100 count

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

Comfort EZ - 00850002860214 Catalog Number : 50002-0860-21

Device Description : Insulin Syringe - 100 count

Device Class :

Duns Number: 116722847

Premarket Exempt : No

Product Code : FMF

Prescription Use : No

Device Count : 100

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