Apex (Guangzhou) Tools & Orthopedics Co.

Address:25 Yonghua Road,Guangzhou Guangdong,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) (10)

Premarket Exempt

Yes

Clear

itool® ApexPulse™ - 06957277200173 Catalog Number : 201-00-80

Device Description : 6" SPLASH SHIELD

Device Class :

Duns Number: 529936792

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : Yes

Device Count : 6

MicroPort® - 06957277200180 Catalog Number : 2010300

Device Description : KNEE KIT

Device Class :

Duns Number: 529936792

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : Yes

Device Count : 6

MicroPort® - 06957277200197 Catalog Number : 2010400

Device Description : HIP KIT

Device Class :

Duns Number: 529936792

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : Yes

Device Count : 6

MicroPort® - 06957277200203 Catalog Number : 201-00-52

Device Description : FEMORAL BRUSH TIP

Device Class :

Duns Number: 529936792

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : Yes

Device Count : 6

AWI - 06957277200326 Catalog Number :

Device Description : PULSE IRRIGATOR

Device Class : 2

Duns Number: 529936792

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 1

AWI - 06957277200333 Catalog Number :

Device Description : PULSE IRRIGATOR

Device Class :

Duns Number: 529936792

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 10

AWI - 06957277200340 Catalog Number :

Device Description : TUNNEL TIP

Device Class :

Duns Number: 529936792

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 10

AWI - 06957277200357 Catalog Number :

Device Description : STANDARD TIP

Device Class : 2

Duns Number: 529936792

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 1

AWI - 06957277200364 Catalog Number :

Device Description : STANDARD TIP

Device Class :

Duns Number: 529936792

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 3

AWI - 06957277200371 Catalog Number :

Device Description : STANDARD TIP

Device Class :

Duns Number: 529936792

Premarket Exempt : Yes

Product Code : FQH

Prescription Use : No

Device Count : 10

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