Apex (Suzhou) Medical Products Company

Address:Part A, 6th of Modern Industry Building, No.333, XingPu Road,SuZhou Jiangsu,CN

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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

Lavage, Jet (FQH) (8) Bag, Drainage, With Adhesive, Ostomy (FON) (2)

Premarket Exempt

Yes

Clear

iTool® APEXPULSE™ - 06972130470012 Catalog Number : 201-02-00

Device Description : Disposable Pulse Lavage Component Kit

Device Class :

Duns Number: 554507451

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 6

iTool® APEXPULSE™ - 06972130470029 Catalog Number : 201-03-00

Device Description : Disposable Pulse LavageKnee Kit

Device Class : 2

Duns Number: 554507451

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 6

MICROAIRE® - 06972130470135 Catalog Number : 201-03-00

Device Description : Disposable Pulse LavageKnee Kit

Device Class : 2

Duns Number: 554507451

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 6

MICROAIRE® - 06972130470142 Catalog Number : 201-04-00

Device Description : Disposable Pulse Lavage Hip Kit

Device Class : 2

Duns Number: 554507451

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 6

MICROAIRE® - 06972130470197 Catalog Number : 201-00-50

Device Description : Disposable Pulse Lavage Tips Shower Spray Tip

Device Class : 2

Duns Number: 554507451

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 6

MICROAIRE® - 06972130470210 Catalog Number : 201-00-52

Device Description : Disposable Pulse Lavage Tips Femoral Brush Tip

Device Class : 2

Duns Number: 554507451

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 6

AWI - 06972130470388 Catalog Number :

Device Description : Disposable Irrigation Bag(Apply to Extremity)

Device Class : 1

Duns Number: 554507451

Premarket Exempt : Yes

Product Code : FON

Prescription Use : No

Device Count : 1

AWI - 06972130470395 Catalog Number :

Device Description : Disposable Irrigation Bag(Apply to Trunk-L)

Device Class : 1

Duns Number: 554507451

Premarket Exempt : Yes

Product Code : FON

Prescription Use : No

Device Count : 1

AWI - 06972130470401 Catalog Number :

Device Description : Tunnel Tip

Device Class : 2

Duns Number: 554507451

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 1

AWI - 06972130470418 Catalog Number :

Device Description : Hydra Adaptor

Device Class : 2

Duns Number: 554507451

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 1

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