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) (9) CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) (DSA) (1)

Premarket Exempt

No Yes

Clear

N/A - 00885825000240 Catalog Number : 1171-17-RT

Device Description : Diagnostic EP Catheter Ismus, 7F.

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000257 Catalog Number : BD710DF282CT

Device Description : Diagnostic EP Catheter DF, 7F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000264 Catalog Number : BD710DF282RTS

Device Description : Diagnostic EP Catheter DF, 7F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000271 Catalog Number : BD710FJ282CT

Device Description : Diagnostic EP Catheter FJ, 7F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000288 Catalog Number : BD710FJ282RTS

Device Description : Diagnostic EP Catheter FJ, 7F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000349 Catalog Number : C3-MR/MST10-SA

Device Description : EP Catheter Cable, Pins 10

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : DSA

Prescription Use : Yes

Device Count : 1

N/A - 00885825000592 Catalog Number : D5-08D-005-RT

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

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000608 Catalog Number : D5-08D-P10-FS

Device Description : Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 8 electrodes, 2-8-2mm s Steerable Diagnostic EP Catheter , D-CURVE (DEF/6.4 CM), 8 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 - 00885825000615 Catalog Number : D5-08D-P10-RT

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

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

N/A - 00885825000622 Catalog Number : D5-10DR-P10-RT

Device Description : Steerable Diagnostic EP Catheter , D-TYPE, 10 electrodes, 2-8-2mm spacing, 5F

Device Class : 2

Duns Number: 020198912

Premarket Exempt : No

Product Code : NLH

Prescription Use : Yes

Device Count : 1

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