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 - 00885825000110 Catalog Number : 6FMC00773

Device Description : Diagnostic EP Catheter, HIS curve, 8 electrodes, 2-60-5-5-5-5-5mm spacing, 6F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000158 Catalog Number : 107832-RT

Device Description : Deflectable Curve EP Catheter, D-CURVE (DEF/6.4 CM), 4 electrodes, 5mm spacing, 5F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000165 Catalog Number : 1079206RT

Device Description : Deflectable Curve EP Catheter , D-CURVE (DEF/6.4 CM), 6 electrodes, 2-5-2-100-2m Deflectable Curve EP Catheter , D-CURVE (DEF/6.4 CM), 6 electrodes, 2-5-2-100-2mm spacing, 6F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000172 Catalog Number : 1085-122-RT

Device Description : Diagnostic EP Catheter P-Curve (Fixed/Supra CS) ,2-8-2mm electrodes, 2-8-2mm spacing, 5F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000189 Catalog Number : 1086-182-RT

Device Description : Diagnostic EP Catheter B-Curve (RED) ,5-50-5-5-5-5-5mm electrodes, 5-50-5-5-5-5- Diagnostic EP Catheter B-Curve (RED) ,5-50-5-5-5-5-5mm electrodes, 5-50-5-5-5-5-5mm spacing, 6F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000196 Catalog Number : 1086-223-RT

Device Description : Diagnostic EP Catheter A-Curve (Josephson/YLW) ,5-75-5-5-5-5-5-mm electrodes, 5- Diagnostic EP Catheter A-Curve (Josephson/YLW) ,5-75-5-5-5-5-5-mm electrodes, 5-75-5-5-5-5-5-mm spacing, 6F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000202 Catalog Number : 1086-259-RT

Device Description : Diagnostic EP Catheter A-Curve (Josephson/YLW) ,2-2-2-2-250mm electrodes, 2-2-2- Diagnostic EP Catheter A-Curve (Josephson/YLW) ,2-2-2-2-250mm electrodes, 2-2-2-2-250mm spacing, 6F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000219 Catalog Number : 1086-515-RT

Device Description : D-Curve (Damato/BLU) ,5-40-2-2-2-2-2mm electrodes, 5-40-2-2-2-2-2mm spacing, 6F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000226 Catalog Number : 1086574S

Device Description : Diagnostic EP Catheter Santoro, 6F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000233 Catalog Number : 1160-08-RT

Device Description : Diagnostic EP Catheter Halo, 7F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

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