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) (10)

Premarket Exempt

No Yes

Clear

Unistik 3 - 00384701004018 Catalog Number :

Device Description : Unistik 3 Normal - 23G 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 - 00384701007019 Catalog Number :

Device Description : Unistik 3 Normal - 23G 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 - 00384701008016 Catalog Number :

Device Description : Unistik 3 Normal 23G 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 - 00384701012013 Catalog Number :

Device Description : Unistik 3 Extra - 21G x 2.0mm, sterile, single use safety lancet

Device Class :

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

Unistik 3 - 00384701013010 Catalog Number :

Device Description : Unistik 3 Extra 21G x 2.0mm, 1000 count - sterile, single use safety lancet

Device Class :

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1000

Unistik 3 - 00384701014017 Catalog Number :

Device Description : Unistik 3 Extra - 21G 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

Unistik 3 - 00384701018015 Catalog Number :

Device Description : Unistik 3 Extra - 21G x 2.0 - 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 - 00384701022012 Catalog Number :

Device Description : Unistik 3 Gentle - 30G x 1.5mm, Sterile, single use safety lancet

Device Class :

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

Unistik 3 - 00384701024016 Catalog Number :

Device Description : Unistik 3 Gentle - 30G x 1.5mm - Sterile, single use safety lancet

Device Class :

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 200

Unistik 3 - Comfort 28G - 00384701042010 Catalog Number :

Device Description : Sterile, single use safety lancet

Device Class :

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

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