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

Blade, Scalpel (GES) (7) Lancet, Blood (FMK) (1) Multiple Use Blood Lancet For Single Patient Use Only (QRL) (1) Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (FMK) (1)

Premarket Exempt

No Yes

Clear

Sterilance LDE3 - 06945630112898 Catalog Number :

Device Class :

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

STERILANCE - 06945630113864 Catalog Number :

Device Class : 2

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : QRL

Prescription Use : No

Device Count : 1

Sterilance Soft Twist Lancet - 16945630101417 Catalog Number :

Device Description : Sterilance Soft Twist Lancet,28G,100Lancets/box

Device Class : 2

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

Carbon Steel Surgical Blade - 16945630101806 Catalog Number :

Device Description : Carbon Steel Surgical Blade,11#,100pcs/box

Device Class : 1

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : GES

Prescription Use : No

Device Count : 100

Carbon Steel Surgical Blade - 16945630101813 Catalog Number :

Device Description : Carbon Steel Surgical Blade,100pcs/box,10#

Device Class : 1

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : GES

Prescription Use : No

Device Count : 100

Carbon Steel Surgical Blade - 16945630102094 Catalog Number :

Device Description : Carbon Steel Surgical Blade,12#,100pcs/box

Device Class : 1

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : GES

Prescription Use : No

Device Count : 100

Carbon Steel Surgical Blade - 16945630102186 Catalog Number :

Device Description : Carbon Steel Surgical Blade,16#,100pcs/box

Device Class : 1

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : GES

Prescription Use : No

Device Count : 100

Carbon Steel Surgical Blade - 16945630102216 Catalog Number :

Device Description : Carbon Steel Surgical Blade,20#,100pcs/box

Device Class : 1

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : GES

Prescription Use : No

Device Count : 100

Carbon Steel Surgical Blade - 16945630102223 Catalog Number :

Device Description : Carbon Steel Surgical Blade,21#,100pcs/box

Device Class : 1

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : GES

Prescription Use : No

Device Count : 100

Carbon Steel Surgical Blade - 16945630102230 Catalog Number :

Device Description : Carbon Steel Surgical Blade,22#,100pcs/box

Device Class : 1

Duns Number: 554434897

Premarket Exempt : Yes

Product Code : GES

Prescription Use : No

Device Count : 100

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