ELI LILLY AND COMPANY

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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) (5) Needle, Hypodermic, Single Lumen (FMI) (3)

Premarket Exempt

Clear

ZYPREXA® Relprevv™ 210 mg Convenience Kit - 00300027635118 Catalog Number : VL7635

Device Description : Combination Drug/Device Convenience Kit: 1 - vial of Zyprexa Relprevv 210mg/vial

Device Class :

Duns Number: 006421325

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

ZYPREXA® Relprevv™ 300 mg Convenience Kit - 00300027636115 Catalog Number : VL7636

Device Description : Combination Drug/Device Convenience Kit: 1 - vial of Zyprexa Relprevv 300 mg/via

Device Class : 2

Duns Number: 006421325

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

ZYPREXA® Relprevv™ 405 mg Convenience Kit - 00300027637112 Catalog Number : VL7637

Device Description : Combination Drug/Device Convenience Kit: 1 - vial of Zyprexa Relprevv 405mg/vial

Device Class : 2

Duns Number: 006421325

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

HumatroPen® 6 mg - 00300029560012 Catalog Number : MS9560

Device Description : HumatroPen 6 mg is a reusable pen injector intended for use with Humatrope 6 mg

Device Class :

Duns Number: 006421325

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

HumatroPen® 12 mg - 00300029561019 Catalog Number : MS9561

Device Description : HumatroPen 12 mg is a reusable pen injector intended for use with Humatrope 12 m

Device Class : 2

Duns Number: 006421325

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

HumatroPen® 24 mg - 00300029562016 Catalog Number : MS9562

Device Description : HumatroPen 24 mg is a reusable pen injector intended for use with Humatrope 24 m

Device Class : 2

Duns Number: 006421325

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

HumaPen® Luxura™ HD - 00300029673019 Catalog Number : MS9673

Device Description : HumaPen Luxura HD is a reusable pen injector intended for use with Lilly 3 mL in

Device Class :

Duns Number: 006421325

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

HumaPen® Luxura™ HD - SAMPLE - 00300029675013 Catalog Number : MS9675

Device Description : HumaPen Luxura HD is a reusable pen injector intended for use with Lilly 3 mL in

Device Class : 2

Duns Number: 006421325

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

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