JEDMED INSTRUMENT COMPANY

Address:5416 JEDMED CT.,Saint Louis,MO,63129,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

Otoscope (ERA) (7) Unit, Examining/Treatment, Ent (ETF) (3)

Premarket Exempt

No Yes

Clear

JEDMED - M6330361110 Catalog Number : 03-6111

Device Description : TUBING HANGER LVCB W/ AUTO SUCT/ PRES

Device Class : 1

Duns Number: 092987189

Premarket Exempt : Yes

Product Code : ETF

Prescription Use : Yes

Device Count : 1

JEDMED - M6330361130 Catalog Number : 03-6113

Device Description : FOOTSWITCH LOW-VOLTAGE CB

Device Class : 1

Duns Number: 092987189

Premarket Exempt : Yes

Product Code : ETF

Prescription Use : Yes

Device Count : 1

JEDMED - M6330361150 Catalog Number : 03-6115

Device Description : REMOTE POWER MODULE LVCB

Device Class : 1

Duns Number: 092987189

Premarket Exempt : Yes

Product Code : ETF

Prescription Use : Yes

Device Count : 1

JEDMED - M6330361210 Catalog Number : 03-6121

Device Description : K2 Recharger System W/ Handle 120V

Device Class : 1

Duns Number: 092987189

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : Yes

Device Count : 1

JEDMED - M6330361220 Catalog Number : 03-6122

Device Description : K2 Recharger System Complete 120V

Device Class : 1

Duns Number: 092987189

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : Yes

Device Count : 1

JEDMED - M6330361230 Catalog Number : 03-6123

Device Description : K2 RECHARGER WELL ONLY 12Vdc

Device Class : 1

Duns Number: 092987189

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : Yes

Device Count : 1

JEDMED - M6330361300 Catalog Number : 03-6130

Device Description : K2 RECHARGER DC POWER SUPPLY 120V

Device Class : 1

Duns Number: 092987189

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : Yes

Device Count : 1

JEDMED - M6330361310 Catalog Number : 03-6131

Device Description : K2 RECHARGER DC POWER SUPPLY 240V

Device Class : 1

Duns Number: 092987189

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : Yes

Device Count : 1

JEDMED - M6330361320 Catalog Number : 03-6132

Device Description : K2 RECHARGER BASE SYSTEM 240V

Device Class : 1

Duns Number: 092987189

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : Yes

Device Count : 1

JEDMED - M6330361350 Catalog Number : 03-6135

Device Description : K2 RECHARGER WELL UNIT ONLY F/ LVCB

Device Class : 1

Duns Number: 092987189

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : Yes

Device Count : 1

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