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) (6) Stent, Vaginal (KXP) (4)

Premarket Exempt

No Yes

Clear

Unistik Touch - 00384701412011 Catalog Number :

Device Description : Unistik Touch - Contact Activated Safety Lancet - 21G x 2.0mm - sterile, single Unistik Touch - Contact Activated Safety Lancet - 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 Touch - 00384701414015 Catalog Number :

Device Description : Unistik Touch - Contact Activated Safety Lancet - 21G x 2.0mm - 200 count - ste Unistik Touch - Contact Activated Safety Lancet - 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 Touch - 00384701422010 Catalog Number :

Device Description : Unistik Touch - Contact Activated Safety Lancet - 30G x 1.5mm - sterile single Unistik Touch - Contact Activated Safety Lancet - 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 Touch - 00384701424014 Catalog Number :

Device Description : Unistik Touch - Contact Activated Safety Lancet - 30G x 1.5mm - 200 count - ster Unistik Touch - Contact Activated Safety Lancet - 30G x 1.5mm - 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 Touch - 00384701442018 Catalog Number :

Device Description : Unistik Touch - Contact Activated Safety Lancet - 28G x 1.8mm - sterile single u Unistik Touch - Contact Activated Safety Lancet - 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 : 100

Unistik Touch - 00384701444012 Catalog Number :

Device Description : Unistik Touch - Contact Activated Safety Lancet - 28G x 1.8mm - 200 count - ste Unistik Touch - Contact Activated Safety Lancet - 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

Amielle - 00384702171016 Catalog Number : SM 2171

Device Description : Vaginal dilator cone size 1

Device Class :

Duns Number: 217266915

Premarket Exempt : No

Product Code : KXP

Prescription Use : Yes

Device Count : 100

Amielle - 00384702172013 Catalog Number : SM 2172

Device Description : Vaginal dilator cone Size 2

Device Class :

Duns Number: 217266915

Premarket Exempt : No

Product Code : KXP

Prescription Use : Yes

Device Count : 100

Amielle - 00384702173010 Catalog Number : SM 2173

Device Description : Vaginal dilator cone Size 3

Device Class :

Duns Number: 217266915

Premarket Exempt : No

Product Code : KXP

Prescription Use : Yes

Device Count : 100

Amielle - 00384702174017 Catalog Number : SM 2174

Device Description : Amielle Cone Size 4 is intended to be inserted into the vagina and progressively Amielle Cone Size 4 is intended to be inserted into the vagina and progressively dilate the vagina

Device Class :

Duns Number: 217266915

Premarket Exempt : No

Product Code : KXP

Prescription Use : Yes

Device Count : 100

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