Sarstedt Aktiengesellschaft & Co.KG

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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

Tubes, Vials, Systems, Serum Separators, Blood Collection (JKA) (10)

Premarket Exempt

No Yes

Clear

S-Monovette® - 04038917128087 Catalog Number : 02.1388.001

Device Description : S-Monovette® 9ml Z-Gel

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : No

Device Count : 50

S-Monovette® - 04038917128506 Catalog Number : 03.1397.100

Device Description : S-Monovette® 5.5ml Z

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : No

Device Count : 50

Safety-Needle - 04038917129190 Catalog Number : 85.1440.200

Device Description : Safety-Needle 22Gx1½"

Device Class :

Duns Number: 388000270

Premarket Exempt : No

Product Code : JKA

Prescription Use : Yes

Device Count : 50

Safety-Needle - 04038917129206 Catalog Number : 85.1441.200

Device Description : Safety-Needle 22Gx1"

Device Class :

Duns Number: 388000270

Premarket Exempt : No

Product Code : JKA

Prescription Use : Yes

Device Count : 50

S-Monovette® - 04038917129701 Catalog Number : 03.1524.001

Device Description : S-Monovette® 4.7ml Z-Gel

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : No

Device Count : 50

S-Monovette® - 04038917130431 Catalog Number : 05.1553.100

Device Description : S-Monovette® 2.7ml LH

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : No

Device Count : 50

S-Monovette® - 04038917130691 Catalog Number : 05.1557.100

Device Description : S-Monovette® 2.7ml Z

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : No

Device Count : 50

S-Monovette® - 04038917131773 Catalog Number : 01.1601.100

Device Description : S-Monovette® 7.5ml Z

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : No

Device Count : 50

S-Monovette® - 04038917131797 Catalog Number : 01.1602.001

Device Description : S-Monovette® 7.5ml Z-Gel

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : No

Device Count : 50

S-Monovette® - 04038917131919 Catalog Number : 01.1604.100

Device Description : S-Monovette® 7.5ml LH

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : No

Device Count : 50

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