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 Combination Drug/Device Convenience Kit: 1 - vial of Zyprexa Relprevv 210mg/vial (VL7635)1 - 3 mL vial of Diluent1 - 3 mL syringe w pre-attached Jelco 19-gauge 1.5 inch Hypodermic Needle-Pro need with needle protection device (EL31915 - GTIN 00351688072545) 2 - Jelco 19 gauge 1.5 inch Hypodermic Needle-Pro needles with needle protection device (EL1915 - GTIN 20351688075670)

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 Combination Drug/Device Convenience Kit: 1 - vial of Zyprexa Relprevv 300 mg/vial (VL7636)1 - 3 mL vial of Diluent1 - 3 mL syringe w pre-attached Jelco 19-gauge 1.5 inch Hypodermic Needle-Pro need with needle protection device (EL31915 - GTIN 00351688072545) 2 - Jelco 19 gauge 1.5 inch Hypodermic Needle-Pro needles with needle protection device (EL1915 - GTIN 20351688075670)

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 Combination Drug/Device Convenience Kit: 1 - vial of Zyprexa Relprevv 405mg/vial (VL7637)1 - 3 mL vial of Diluent1 - 3 mL syringe w pre-attached Jelco 19-gauge 1.5 inch Hypodermic Needle-Pro need with needle protection device (EL31915 - GTIN 00351688072545) 2 - Jelco 19 gauge 1.5 inch Hypodermic Needle-Pro needles with needle protection device (EL1915 - GTIN 20351688075670)

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 HumatroPen 6 mg is a reusable pen injector intended for use with Humatrope 6 mg cartridges.

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 HumatroPen 12 mg is a reusable pen injector intended for use with Humatrope 12 mg cartridges

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 HumatroPen 24 mg is a reusable pen injector intended for use with Humatrope 24 mg cartridges

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 HumaPen Luxura HD is a reusable pen injector intended for use with Lilly 3 mL insulin cartridges.

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 HumaPen Luxura HD is a reusable pen injector intended for use with Lilly 3 mL insulin cartridges. Designated for sample use.

Device Class : 2

Duns Number: 006421325

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

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