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 - 00885825000738 Catalog Number : D6-08DR-252-RT

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 8 electrodes, 2-5-2mm spacing, 6F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000745 Catalog Number : D6-10DR-002-FS

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 4 electrodes, 2mm spacing, 6F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000752 Catalog Number : D6-10DR-002-RT

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 10 electrodes, 2mm spacing, 6F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000769 Catalog Number : D6-10DR-005-FS

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 10 electrodes, 5mm spacing, 6F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000776 Catalog Number : D6-10DR-005-RT

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 10 electrodes, 5mm spacing, 6F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000783 Catalog Number : D6-10DR-252-RT

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 10 electrodes, 2-5-2mm Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 10 electrodes, 2-5-2mm spacing, 6F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000790 Catalog Number : D610DRP10CT

Device Description : Steerable with Auto ID Diagnostic EP Catheter, D-CURVE (DEF/6.4 CM), 10 electrod Steerable with Auto ID Diagnostic EP Catheter, D-CURVE (DEF/6.4 CM), 10 electrodes, 2-8-2mm spacing, 6F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000806 Catalog Number : D6-10DR-P10-FS

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 10 electrodes, 2-8-2mm Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 10 electrodes, 2-8-2mm spacing, 6F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000813 Catalog Number : D6-10DR-P10-RT

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 10 electrodes, 2-8-2mm Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 10 electrodes, 2-8-2mm spacing, 6F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000820 Catalog Number : D6-10FR-005-FS

Device Description : Steerable Diagnostic EP Catheter , F-CURVE (DEF/7.6 CM), 10 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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