ASAHI POLYSLIDER COMPANY,LIMITED

Address:860-2 Misaki,Maniwa Okayama,JP

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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

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (QRK) (6) Lancet, Blood (FMK) (2) Multiple Use Blood Lancet For Single Patient Use Only (QRL) (1)

Premarket Exempt

No Yes

Clear

OneTouch Delica Plus Lancet - 00812608030019 Catalog Number : OTDP Lancet 33g 100 US

Device Description : Box of 100 Sterile Lancets 33 Gauge

Device Class :

Duns Number: 718296825

Premarket Exempt : No

Product Code : QRK

Prescription Use : No

Device Count : 100

OneTouch Delica Plus Lancet - 00812608030026 Catalog Number : OTDP Lancet 30g 100 US

Device Description : Box of 100 Sterile Lancets 30 Gauge

Device Class :

Duns Number: 718296825

Premarket Exempt : No

Product Code : QRK

Prescription Use : No

Device Count : 100

OneTouch Delica Plus Lancet - 00812608030033 Catalog Number : OTDP Lancet Bag 33g US/CA

Device Description : Bag of 10 sterile lancets 33 Gauge

Device Class :

Duns Number: 718296825

Premarket Exempt : No

Product Code : QRK

Prescription Use : No

Device Count : 10

OneTouch Delica Plus Lancet - 00812608030040 Catalog Number : OTDP Lancet Bag 30g US/CA

Device Description : Bag of 10 sterile lancets 30 Gauge

Device Class :

Duns Number: 718296825

Premarket Exempt : No

Product Code : QRK

Prescription Use : No

Device Count : 10

OneTouch Delica Plus Lancing Device - 00812608030057 Catalog Number : OTDP Lancing Device US

Device Description : Box of 1 Lancing Device and 10 Sterile Lancets 30 Gauge

Device Class : 2

Duns Number: 718296825

Premarket Exempt : No

Product Code : QRL, QRK

Prescription Use : No

Device Count : 1

OneTouch Delica Plus Lancet - 00812608030217 Catalog Number : OTDP Lancet 30g 30 US

Device Description : Box of 30 Sterile Lancets 30 Gauge

Device Class :

Duns Number: 718296825

Premarket Exempt : No

Product Code : QRK

Prescription Use : No

Device Count : 30

OneTouch Delica Safety - 00812608030224 Catalog Number : OTD Safety 30g US/CA/LATAM 200

Device Description : Box of 200 Sterile Single-Use Lancing Device 30Gauge

Device Class :

Duns Number: 718296825

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 200

OneTouch Delica Safety - 00812608030231 Catalog Number : OTD Safety 23g US/CA 200

Device Description : Box of 200 Sterile Single-Use Lancing Device 23 Gauge

Device Class :

Duns Number: 718296825

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 200

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