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) (10)

Premarket Exempt

No Yes

Clear

MYO/Wire® Ultra-Thin Temporary Pacing Wires - 08718627410004 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 - 08718627410028 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 - 08718627410042 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 - 08718627410066 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 - 08718627410080 Catalog Number :

Device Description : MYO/Wire® Ultra-Thin Bipolar Inline - 200cm - Blue - Flare 4mm 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 - 08718627410103 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 - 08718627410127 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 - 08718627410141 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 - 08718627410165 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 - 08718627410189 Catalog Number :

Device Description : MYO/Wire® Ultra-Thin Bipolar Inline - 60cm - Blue - Flare 4mm electrode

Device Class : 2

Duns Number: 173770868

Premarket Exempt : No

Product Code : LDF

Prescription Use : No

Device Count : 1

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