Shanghai Kinetic Medical Co., Ltd.

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

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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) Orthopedic Manual Surgical Instrument (LXH) (2)

Premarket Exempt

Yes No

Clear

Balloon Catheter Syringe Pump - 06938695537775 Catalog Number : FG4011

Device Description : Balloon Catheter Syringe Pump, Tube Length 30cm

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : NDN, HRX

Prescription Use : Yes

Device Count : 1

Balloon Catheter Syringe Pump - 06938695537782 Catalog Number : FG4013

Device Description : Balloon Catheter Syringe Pump, Tube Length 60cm

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : NDN, HRX

Prescription Use : Yes

Device Count : 1

Curette - 06938695537799 Catalog Number : FG9011

Device Description : Curette

Device Class : 1

Duns Number: 528198569

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Balloon Catheter - 06938695537805 Catalog Number : FA1110

Device Description : Balloon Catheter, 10mm

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : HRX, NDN

Prescription Use : Yes

Device Count : 1

Balloon Catheter - 06938695537812 Catalog Number : FA1115

Device Description : Balloon Catheter, 15mm

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : HRX, NDN

Prescription Use : Yes

Device Count : 1

Balloon Catheter - 06938695537829 Catalog Number : FA1120

Device Description : Balloon Catheter, 20mm

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : HRX, NDN

Prescription Use : Yes

Device Count : 1

Balloon Catheter Curved - 06938695537836 Catalog Number : LC10215

Device Description : Balloon Catheter Curved, 15mm, 45°

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : HRX, NDN

Prescription Use : Yes

Device Count : 1

Balloon Catheter Curved - 06938695537843 Catalog Number : LC10220

Device Description : Balloon Catheter Curved, 20mm, 45°

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : HRX, NDN

Prescription Use : Yes

Device Count : 1

Balloon Catheter Curved - 06938695537850 Catalog Number : LC10225

Device Description : Balloon Catheter Curved, 25mm, 45°

Device Class : 2

Duns Number: 528198569

Premarket Exempt : No

Product Code : HRX, NDN

Prescription Use : Yes

Device Count : 1

Curved Curette - 06938695537867 Catalog Number : VO1113

Device Description : Curved Curette

Device Class : 1

Duns Number: 528198569

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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