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) (8) Esthesiometer (GXB) (2)

Premarket Exempt

No Yes

Clear

Neuropen - 00384700100018 Catalog Number :

Device Description : Non sterile, sensory neuropathy screening device

Device Class : 1

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : GXB

Prescription Use : No

Device Count : 1

Neuropen Monofilaments 10g - 00384700104016 Catalog Number :

Device Description : Monofilaments for neuropathy screening

Device Class :

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : GXB

Prescription Use : No

Device Count : 5

Unistik - 00384700702014 Catalog Number :

Device Description : Unistik Normal, 23G 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 - 00384700704018 Catalog Number :

Device Description : Unistik 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 - 00384700712013 Catalog Number :

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

Device Class :

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

Unistik - 00384700714017 Catalog Number :

Device Description : Unistik 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 - 00384700747015 Catalog Number :

Device Description : Unistik 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 : 200

Unistik 2 Safety Lancets - Super 21G - 00384700752019 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

Unistik 3 - 00384701002014 Catalog Number :

Device Description : Unistik 3 Normal - 23G 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 - 00384701003011 Catalog Number :

Device Description : Unistik 3 Normal 23G x 1.8mm, 1000 count - sterile, single use safety lancet

Device Class :

Duns Number: 217266915

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1000

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