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 - 00885825000936 Catalog Number : D6R-20-P12-RT

Device Description : Diagnostic EP Catheter Ismus, 6F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000943 Catalog Number : D6R-20-P14-FS

Device Description : Diagnostic EP Catheter Ismus, 6F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000950 Catalog Number : D6S-08DR-PRY-FS

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM),8 electrodes, 2.5-10-2.5 Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM),8 electrodes, 2.5-10-2.5-2.5-2.5-5-2.5mm spacing, 6F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000967 Catalog Number : D6S-08DR-PRY-RT

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM),8 electrodes, 2-10-2-2-2 Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM),8 electrodes, 2-10-2-2-2-5-2mm spacing, 6F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000974 Catalog Number : D7-06DL-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, 7F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000981 Catalog Number : D7-06DR-002-RT

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 6 electrodes, 2mm spacing, 7F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000998 Catalog Number : D7-06FR-002-RT

Device Description : Diagnostic EP Catheter F-Curve (Deflectable) ,2mm electrodes, 2mm spacing, 7F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825001001 Catalog Number : D7-08AR-002-RT

Device Description : Steerable Diagnostic EP Catheter , A-CURVE (DEF/3.8 CM), 8 electrodes, 2.5-3.75- Steerable Diagnostic EP Catheter , A-CURVE (DEF/3.8 CM), 8 electrodes, 2.5-3.75-2.5-2.5-2.5-2.5-2.5mm spacing, 7F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825001018 Catalog Number : D7-08BR-002-RT

Device Description : Steerable Diagnostic EP Catheter , B-CURVE (DEF/5.1 CM), 8 electrodes, 2.5-3.75- Steerable Diagnostic EP Catheter , B-CURVE (DEF/5.1 CM), 8 electrodes, 2.5-3.75-2.5-2.5-2.5-2.5-2.5mm spacing, 7F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825001025 Catalog Number : D7-08DL-002-FS

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 8 electrodes, 2.5-4-2.5 Steerable 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, 7F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

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