Tz Medical, Inc.

Address:17750 SW Upper Boones Ferry Rd Ste 150,PORTLAND,OR,97224,US

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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

Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) (DRO) (10)

Premarket Exempt

Yes

Clear

Defibrillation Electrodes - 10811331010326 Catalog Number :

Device Description : ADULT, RADIOTRANSLUCENT ELEMENT

Device Class : 2

Duns Number: 793149709

Premarket Exempt : Yes

Product Code : DRO

Prescription Use : Yes

Device Count : 10

Defibrillation Electrodes - 10811331010333 Catalog Number :

Device Description : ADULT, RADIOTRANSLUCENT ELEMENT, COMPATIBLE W/ ZOLL

Device Class : 2

Duns Number: 793149709

Premarket Exempt : Yes

Product Code : DRO

Prescription Use : Yes

Device Count : 10

Defibrillation Electrodes - 10811331010340 Catalog Number :

Device Description : PEDIATRIC (3x3 1/4"), RADIOTRANSLUCENT ELEMENT

Device Class : 2

Duns Number: 793149709

Premarket Exempt : Yes

Product Code : DRO

Prescription Use : Yes

Device Count : 10

Defibrillation Electrodes - 10811331010357 Catalog Number :

Device Description : ADULT (STERILE), RADIOTRANSLUCENT ELEMENT

Device Class : 2

Duns Number: 793149709

Premarket Exempt : Yes

Product Code : DRO

Prescription Use : Yes

Device Count : 10

Defibrillation Electrodes - 10811331010364 Catalog Number :

Device Description : PEDIATRIC STERILE (3 X 3 1/4"), RADIOTRANSLUCENT ELEMENT

Device Class : 2

Duns Number: 793149709

Premarket Exempt : Yes

Product Code : DRO

Prescription Use : Yes

Device Count : 10

Defibrillation Electrodes - 10811331010371 Catalog Number :

Device Description : ADULT, RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ MEDTRONIC

Device Class : 2

Duns Number: 793149709

Premarket Exempt : Yes

Product Code : DRO

Prescription Use : Yes

Device Count : 10

Defibrillation Electrodes - 10811331010388 Catalog Number :

Device Description : ADULT, RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ GRAY FLAT CONNECTOR

Device Class : 2

Duns Number: 793149709

Premarket Exempt : Yes

Product Code : DRO

Prescription Use : Yes

Device Count : 10

Defibrillation Electrodes - 10811331010395 Catalog Number :

Device Description : ADULT, RADIOTRANSPARENT ELEMENT AND LEAD WIRE

Device Class : 2

Duns Number: 793149709

Premarket Exempt : Yes

Product Code : DRO

Prescription Use : Yes

Device Count : 10

Defibrillation Electrodes - 10811331010401 Catalog Number :

Device Description : ADULT, RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ ZOLL

Device Class : 2

Duns Number: 793149709

Premarket Exempt : Yes

Product Code : DRO

Prescription Use : Yes

Device Count : 10

Defibrillation Electrodes - 10811331010418 Catalog Number :

Device Description : PEDIATRIC,RADIOTRANSPARENT ELEMENT, COMPATIBLE W/ MEDTRONIC

Device Class : 2

Duns Number: 793149709

Premarket Exempt : Yes

Product Code : DRO

Prescription Use : Yes

Device Count : 10

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