STRYKER SUSTAINABILITY SOLUTIONS, INC.

Address:1810 W. Drake Dr.,Tempe,AZ,85283,US

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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

CATHETER, RECORDING, ELECTRODE, REPROCESSED (NLH) (10)

Premarket Exempt

No Yes

Clear

N/A - 00885825000639 Catalog Number : D5S-06AL-252-MS

Device Description : Steerable Diagnostic EP Catheter , A-CURVE (DEF/3.8 CM), 6 electrodes, 2-5-2mm s Steerable Diagnostic EP Catheter , A-CURVE (DEF/3.8 CM), 6 electrodes, 2-5-2mm spacing, 5F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000646 Catalog Number : D5S-06AL-252-RT

Device Description : Steerable Diagnostic EP Catheter , A-CURVE (DEF/3.8 CM), 6 electrodes, 2-5-2mm spacing, 5F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000653 Catalog Number : D5S-AL-252-RT

Device Description : Steerable Diagnostic EP Catheter , A-CURVE (DEF/3.8 CM), 4 electrodes, 2-5-2mm spacing, 5F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000660 Catalog Number : D6-06DR-002-FS

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 6 electrodes, 2.5-4-2.5 Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 6 electrodes, 2.5-4-2.5-2.5-2.5mm spacing, 6F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000677 Catalog Number : D6-06DR-002-RT

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 6 electrodes, 2mm spacing, 6F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000684 Catalog Number : D6-06DR-005-FS

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM),6 electrodes, 5mm spacing, 6F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000691 Catalog Number : D608DR002CT

Device Description : Steerable with Auto ID Diagnostic EP Catheter, D-CURVE (DEF/6.4 CM),8 electrodes Steerable with Auto ID Diagnostic EP Catheter, D-CURVE (DEF/6.4 CM),8 electrodes, 2.5-4-2.5-2.5-2.5-2.5-2.5mm spacing, 6F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000707 Catalog Number : D6-08DR-002-FS

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 8 electrodes, 2mm spacing, 6F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000714 Catalog Number : D6-08DR-002-RT

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 8 electrodes, 2mm spacing, 6F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000721 Catalog Number : D6-08DR-005-RT

Device Description : Diagnostic Catheter D-Curve (Deflectable) ,5mm electrodes, 5mm spacing, 6F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

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