A & E MEDICAL CORPORATION

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

Premarket Exempt

No Yes

Clear

Fastlock - 08718627410974 Catalog Number :

Device Class : 2

Duns Number: 173770868

Premarket Exempt : No

Product Code : DSA

Prescription Use : No

Device Count : 1

MYO/Wire® Ultra-Thin Temporary Pacing Wires - 08718627410998 Catalog Number :

Device Description : MYO/Wire® Ultra-Thin Quadpolar - 60cm - Blue/White - Hook 10mm electrode

Device Class : 2

Duns Number: 173770868

Premarket Exempt : No

Product Code : LDF

Prescription Use : No

Device Count : 1

MYO/Wire® Ultra-Thin Temporary Pacing Wires - 08718627411018 Catalog Number :

Device Class : 2

Duns Number: 173770868

Premarket Exempt : No

Product Code : LDF

Prescription Use : No

Device Count : 1

MYO/Wire® Ultra-Thin Temporary Pacing Wires - 08718627411032 Catalog Number :

Device Description : MYO/Wire® Ultra-Thin Quadpolar - 200cm - Blue/White - Flare/Hook 8/10mm electrode

Device Class : 2

Duns Number: 173770868

Premarket Exempt : No

Product Code : LDF

Prescription Use : No

Device Count : 1

MYO/Wire® Ultra-Thin Temporary Pacing Wires - 08718627411056 Catalog Number :

Device Class : 2

Duns Number: 173770868

Premarket Exempt : No

Product Code : LDF

Prescription Use : No

Device Count : 1

MYO/Wire® Ultra-Thin Temporary Pacing Wires - 08718627411070 Catalog Number :

Device Class : 2

Duns Number: 173770868

Premarket Exempt : No

Product Code : LDF

Prescription Use : No

Device Count : 1

MYO/Wire® Ultra-Thin Temporary Pacing Wires - 08718627411094 Catalog Number :

Device Description : MYO/Wire® Ultra-Thin Quadpolar - 60cm - Blue/White - Flare/Hook 8/10mm electrode

Device Class : 2

Duns Number: 173770868

Premarket Exempt : No

Product Code : LDF

Prescription Use : No

Device Count : 1

MYO/Wire® Ultra-Thin Temporary Pacing Wires - 08718627411117 Catalog Number :

Device Description : MYO/Wire® Ultra-Thin Quadpolar - 60cm - White/Blue - Flare/Hook 8/10mm electrode

Device Class : 2

Duns Number: 173770868

Premarket Exempt : No

Product Code : LDF

Prescription Use : No

Device Count : 1

MYO/Wire® Ultra-Thin Temporary Pacing Wires - 08718627411131 Catalog Number :

Device Class : 2

Duns Number: 173770868

Premarket Exempt : No

Product Code : LDF

Prescription Use : No

Device Count : 1

MYO/Wire® Ultra-Thin Temporary Pacing Wires - 08718627411155 Catalog Number :

Device Class : 2

Duns Number: 173770868

Premarket Exempt : No

Product Code : LDF

Prescription Use : No

Device Count : 1

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