Shanghai Kinetic Medical Co., Ltd.

Address:2F, No.23 Building, 528 Ruiqing Road,East Zhangjiang Shanghai,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

Arthroscope (HRX) (8) Cement, Bone, Vertebroplasty (NDN) (8) Needle, Aspiration And Injection, Disposable (GAA) (2)

Premarket Exempt

Yes No

Clear

Dilator w/Cannula - 06938695537676 Catalog Number : FG2410

Device Description : Dilator w/Cannula, 8G (4.2mm)

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : HRX, NDN

Prescription Use : Yes

Device Count : 1

Bone Filler Device - 06938695537683 Catalog Number : FG2510

Device Description : Bone Filler Device, Flat Tip, 9G (3.5mm)

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : HRX, NDN

Prescription Use : Yes

Device Count : 1

Bone Biopsy Device - 06938695537690 Catalog Number : FG2511

Device Description : Bone Biopsy Device, 9G (3.5mm)

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : NDN, HRX

Prescription Use : Yes

Device Count : 1

Bone Filler Device - 06938695537706 Catalog Number : FG2512

Device Description : Bone Filler Device, Lateral Open Tip, 9G (3.5mm)

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : HRX, NDN

Prescription Use : Yes

Device Count : 1

Bone Filler Device - 06938695537713 Catalog Number : FG2513

Device Description : Bone Filler Device, Bevel Tip, 9G (3.5mm)

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : HRX, NDN

Prescription Use : Yes

Device Count : 1

One-Shot - 06938695537720 Catalog Number : FG2710

Device Description : One-Shot, Pyramid tip, 8G (4.2mm)

Device Class : 1

Duns Number: 528198569

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

One-Shot - 06938695537737 Catalog Number : FG2711

Device Description : One-Shot, Pyramid tip, 9G (3.5mm)

Device Class : 1

Duns Number: 528198569

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Access Needle - 06938695537744 Catalog Number : FG3016

Device Description : Access Needle, Pyramid Tip, 115mm, 11G

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : NDN, HRX

Prescription Use : Yes

Device Count : 1

Access Needle - 06938695537751 Catalog Number : FG3018

Device Description : Access Needle, Intergrated Bevel Tip, 115mm, 11G

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : NDN, HRX

Prescription Use : Yes

Device Count : 1

Access Needle - 06938695537768 Catalog Number : FG3019

Device Description : Access Needle, Intergrated Diamond Tip, 115mm, 11G

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : NDN, HRX

Prescription Use : Yes

Device Count : 1

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