ALPHA MEDICAL INSTRUMENTS

Address:23455 Madero Ste B,MISSION VIEJO,CA,92691,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

Electrode, Pacemaker, Temporary (LDF) (2) Catheter, Flow Directed (DYG) (1)

Premarket Exempt

Clear

Thermodilution 7FR 110cm Modified J-tip - M822474110P0 Catalog Number : 474-110P

Device Description : Thermodilution Catheter

Device Class : 2

Duns Number: 627767577

Premarket Exempt : No

Product Code : DYG

Prescription Use : Yes

Device Count : 1

Bipolar 5FR 110cm Modified-J Shrouded Pins - M822606002 Catalog Number : 652/1-110P

Device Class : 2

Duns Number: 627767577

Premarket Exempt : No

Product Code : LDF

Prescription Use : Yes

Device Count : 1

Bipolar 5FR 110cm Modified-J Shrouded Pins - M8226521110P0 Catalog Number : 625/1-110P

Device Description : Bipolar Balloon Pacing Catheter

Device Class : 2

Duns Number: 627767577

Premarket Exempt : No

Product Code : LDF

Prescription Use : Yes

Device Count : 1

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