Sterilance Medical (Suzhou) Inc.

Address:No.168 PuTuoShan Road,Suzhou Jiangsu,CN

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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 With An Integral Sharps Injury Prevention Feature (FMK) (6) Blade, Scalpel (GES) (2) Lancet, Blood (FMK) (2)

Premarket Exempt

No Yes

Clear

Sterilance SteriHeel Plus Heel Incision Safety Lancet - 16945630110280 Catalog Number :

Device Description : Sterilance SteriHeel Plus Heel Incision Safety Lancet,50Lancets/box,0.85*1.75mm.

Device Class : 2

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 50

Sterilance SteriHeel Plus Heel Incision Safety Lancet - 16945630110297 Catalog Number :

Device Description : Sterilance SteriHeel Plus Heel Incision Safety Lancet,50Lancets/box,0.65*1.40mm.

Device Class : 2

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 50

Sterilance Flex3 Depth Adjustable Safety Lancet - 16945630111898 Catalog Number :

Device Class :

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

Sterilance Flex3 Depth Adjustable Safety Lancet - 16945630111904 Catalog Number :

Device Class :

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1000

Sterilance Flex3 Depth Adjustable Safety Lancet - 16945630111911 Catalog Number :

Device Class :

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

Sterilance Flex3 Depth Adjustable Safety Lancet - 16945630111928 Catalog Number :

Device Class :

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

Sterilance SteriHeel Plus - 16945630111935 Catalog Number :

Device Class :

Duns Number: 554434897

Premarket Exempt : No

Product Code : FMK

Prescription Use : No

Device Count : 50

Sterilance Press Pressure Activated Safety Lancet - 16945630111973 Catalog Number :

Device Class :

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

Surgical Blade Carbon Steel - 16945630112086 Catalog Number :

Device Class :

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : GES

Prescription Use : No

Device Count : 100

Viamed Surgical Blades - 16945630112383 Catalog Number :

Device Class :

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : GES

Prescription Use : No

Device Count : 100

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