MORTARA INSTRUMENT, INC.

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Filters

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

Electrocardiograph (DPS) (10)

Premarket Exempt

Clear

Patient Cable Lead Set - 00812345021882 Catalog Number :

Device Description : Patient cable cleared with ELI 350

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Patient Cable Lead Set - 00812345021899 Catalog Number :

Device Description : Patient cable cleared with ELI 350

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Patient Cable - 00812345021905 Catalog Number :

Device Description : Patient cable cleared with ELI 350

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Patient Cable Lead Set - 00812345021912 Catalog Number :

Device Description : Patient cable cleared with ELI 350

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Patient Cable Lead Set - 00812345021929 Catalog Number :

Device Description : Patient cable cleared with ELI 350

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Patient Cable Lead Set - 00812345021936 Catalog Number :

Device Description : Patient cable cleared with ELI 350

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Patient Cable Lead Set - 00812345021943 Catalog Number :

Device Description : Patient cable cleared with ELI 350

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Patient Cable Lead Set - 00812345021950 Catalog Number :

Device Description : Leadwire set cleared with ELI 280

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Patient Cable Lead Set - 00812345021967 Catalog Number :

Device Description : Leadwire set cleared with ELI 280

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

Patient Cable Lead Set - 00812345021974 Catalog Number :

Device Description : Leadwire set cleared with ELI 280

Device Class : 2

Duns Number: 062046149

Premarket Exempt : No

Product Code : DPS

Prescription Use : Yes

Device Count : 1

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