INSERT MOLDING SOLUTIONS INC

Address:4325 Settingdown Cir Ste 103,Cumming,GA,30028,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

Instrument, Biopsy (KNW) (2) Urinary Drainage Collection Kit, For Indwelling Catheter (FCN) (1)

Premarket Exempt

No Yes

Clear

BioFlo - B567AU170 Catalog Number :

Device Description : BioFlo AutoValve Urine Valve

Device Class :

Duns Number: 031736504

Premarket Exempt : Yes

Product Code : FCN

Prescription Use : Yes

Device Count : 1

M Core - B567MC18200 Catalog Number :

Device Description : Biopsy Needle

Device Class :

Duns Number: 031736504

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

M-Core - B567MC18250 Catalog Number :

Device Description : Disposable Core Biopsy Needle

Device Class :

Duns Number: 031736504

Premarket Exempt : No

Product Code : KNW

Prescription Use : Yes

Device Count : 1

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