OWEN MUMFORD LIMITED

Address:Primsdown Industrial Estate,Chipping Norton Oxfordshire,GB

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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

Lancet, Blood (FMK) (7) Introducer, Syringe Needle (KZH) (3)

Premarket Exempt

No Yes

Clear

Unistik 3 - 00384701043017 Catalog Number :

Device Description : Unistik 3 Comfort 28G x 1.8mm - sterile, single use safety lancet

Device Class :

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1000

Unistik 3 - 00384701044014 Catalog Number :

Device Description : Unistik 3 Comfort 28G x 1.8mm, 200 count - sterile, single use safety lancet

Device Class :

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 200

Unistik 3 - 00384701047015 Catalog Number :

Device Description : Unistik 3 Comfort 28G x 1.8mm, 50 count - sterile, single use safety lancet

Device Class :

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 50

Unistik 3 - 00384701048012 Catalog Number :

Device Description : Unistik 3 Comfort - 28G x 1.8mm - 25 count - sterile, single use safety lancet

Device Class :

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 25

Unistik 3 - 00384701062018 Catalog Number :

Device Description : Unistik 3 Dual 18G x 1.8mm, Sterile, single use safety lancet

Device Class :

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

Unistik 3 - 00384701064012 Catalog Number :

Device Description : Unistik 3 Dual - 18G x 1.8mm - 200 count - sterile, single use safety lancet

Device Class :

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 200

Autoject 2 - 00384701300011 Catalog Number : AJ1300

Device Description : Fixed needle, non-sterile reusable injector.

Device Class :

Duns Number: 217266915

Premarket Exempt : No

Product Code : KZH

Prescription Use : No

Device Count : 1

Autoject EI - 00384701310010 Catalog Number : AJ1310

Device Description : Non-sterile reusable autoinjector device, with an external indicator, for the in Non-sterile reusable autoinjector device, with an external indicator, for the injection of FDA-approved drugs from fixed needle syringes

Device Class :

Duns Number: 217266915

Premarket Exempt : No

Product Code : KZH

Prescription Use : No

Device Count : 1

Autoject 2 - 00384701311017 Catalog Number : AJ1311

Device Description : Removable needle, non-sterile reusable injector.

Device Class :

Duns Number: 217266915

Premarket Exempt : No

Product Code : KZH

Prescription Use : No

Device Count : 1

Unistik Touch - 00384701404016 Catalog Number :

Device Description : Unistik Touch - Contact Activated Safety Lancet - 23G x 2.0mm - 200 count - ster Unistik Touch - Contact Activated Safety Lancet - 23G x 2.0mm - 200 count - sterile, single use safety lancet

Device Class :

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 200

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