ULTIMED, 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) Syringe, Piston (FMF) (5) Syringe, Antistick (MEG) (3)

Premarket Exempt

Clear

UltiCare - 10357515630077 Catalog Number :

Device Class : 2

Duns Number: 024723541

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : No

Device Count : 1

UltiCare - 10357515630084 Catalog Number :

Device Class : 2

Duns Number: 024723541

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : No

Device Count : 1

UltiCare - 10357515630145 Catalog Number :

Device Class : 2

Duns Number: 024723541

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : No

Device Count : 1

UltiCare 8mm pen needle 5-pk - 10357515710052 Catalog Number :

Device Description : UltiCare 8mm x 31G, 5ct

Device Class :

Duns Number: 024723541

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 5

UltiCare 5mm pen needle 5-pk - 10357515710137 Catalog Number :

Device Description : UltiCare 5mm x 31G, 5ct

Device Class :

Duns Number: 024723541

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 5

UltiCare 6mm Pen Needle 5-pk - 10357515710144 Catalog Number :

Device Description : UltiCare 6mm x 31G, 5ct

Device Class :

Duns Number: 024723541

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 5

UltiCare 4mm Pen Needle 5pk - 10357515895438 Catalog Number :

Device Description : UltiCare 4mm x 32G, 5ct

Device Class :

Duns Number: 024723541

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 5

UltiCare 6mm pen needle 5-pack - 10357515895636 Catalog Number :

Device Description : UltiCare 6mm x 31 gauge, 5ct

Device Class :

Duns Number: 024723541

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 5

UltiCare - 10357515950106 Catalog Number :

Device Class :

Duns Number: 024723541

Premarket Exempt : No

Product Code : FMI, FMF

Prescription Use : No

Device Count : 10

UltiCare - 10357515950113 Catalog Number :

Device Class :

Duns Number: 024723541

Premarket Exempt : No

Product Code : FMI, FMF

Prescription Use : No

Device Count : 10

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