Sarstedt Aktiengesellschaft & Co.KG

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) (6) Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use (LXG) (4)

Premarket Exempt

No Yes

Clear

Seraplas - 04038917081481 Catalog Number : 53.419

Device Description : Seraplas V13

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 100

Seraplas - 04038917081498 Catalog Number : 53.420

Device Description : Seraplas V16

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 100

Seraplas - 04038917081528 Catalog Number : 53.428

Device Description : Seraplas V15

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 100

Seraplas - 04038917083317 Catalog Number : 53.677

Device Description : Seraplas V11

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : LXG

Prescription Use : No

Device Count : 100

S-Monovette® - 04038917085212 Catalog Number : 02.1063

Device Description : S-Monovette® 9ml Z

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : No

Device Count : 50

Membrane-Adapter - 04038917085359 Catalog Number : 14.1112

Device Description : Membrane-Adapter

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : No

Device Count : 100

Monovette® - 04038917085458 Catalog Number : 05.1147

Device Description : Monovette® 2ml LH blood gas

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : No

Device Count : 50

Ventilation - 04038917085465 Catalog Number : 14.1148

Device Description : Ventilation for blood gas Monovette

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : No

Device Count : 500

S-Monovette®-Needle - 04038917085519 Catalog Number : 85.1160

Device Description : S-Monovette®-Needle 20Gx1½"

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : Yes

Device Count : 100

S-Monovette®-Needle - 04038917085526 Catalog Number : 85.1162

Device Description : S-Monovette®-Needle 21Gx1½"

Device Class :

Duns Number: 388000270

Premarket Exempt : Yes

Product Code : JKA

Prescription Use : Yes

Device Count : 100

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