OrbusNeich Medical (ShenZhen) Co., Ltd.

Address:No.1st Jinkui Road,SHENZHEN 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

Catheter, Angioplasty, Peripheral, Transluminal (LIT) (10) Catheter, Percutaneous, Cutting/Scoring (PNO) (1)

Premarket Exempt

Clear

Scoreflex PTA Scoring Balloon Catheter - 06934599541269 Catalog Number :

Device Description : Catheter, Percutaneous, Cutting/Scoring

Device Class : 2

Duns Number: 530923226

Premarket Exempt : No

Product Code : PNO, LIT

Prescription Use : Yes

Device Count : 1

Jade PTA Balloon Dilatation Catheter - 06934955900013 Catalog Number :

Device Description : Percutaneous Transluminal Angioplasty (PTA) Catheter

Device Class : 2

Duns Number: 530923226

Premarket Exempt : No

Product Code : LIT

Prescription Use : No

Device Count : 1

Jade PTA Balloon Dilatation Catheter - 06934955900020 Catalog Number :

Device Description : Percutaneous Transluminal Angioplasty (PTA) Catheter

Device Class : 2

Duns Number: 530923226

Premarket Exempt : No

Product Code : LIT

Prescription Use : No

Device Count : 1

Jade PTA Balloon Dilatation Catheter - 06934955900037 Catalog Number :

Device Description : Percutaneous Transluminal Angioplasty (PTA) Catheter

Device Class : 2

Duns Number: 530923226

Premarket Exempt : No

Product Code : LIT

Prescription Use : No

Device Count : 1

Jade PTA Balloon Dilatation Catheter - 06934955900044 Catalog Number :

Device Description : Percutaneous Transluminal Angioplasty (PTA) Catheter

Device Class : 2

Duns Number: 530923226

Premarket Exempt : No

Product Code : LIT

Prescription Use : No

Device Count : 1

Jade PTA Balloon Dilatation Catheter - 06934955900051 Catalog Number :

Device Description : Percutaneous Transluminal Angioplasty (PTA) Catheter

Device Class : 2

Duns Number: 530923226

Premarket Exempt : No

Product Code : LIT

Prescription Use : No

Device Count : 1

Jade PTA Balloon Dilatation Catheter - 06934955900068 Catalog Number :

Device Description : Percutaneous Transluminal Angioplasty (PTA) Catheter

Device Class : 2

Duns Number: 530923226

Premarket Exempt : No

Product Code : LIT

Prescription Use : No

Device Count : 1

Jade PTA Balloon Dilatation Catheter - 06934955900075 Catalog Number :

Device Description : Percutaneous Transluminal Angioplasty (PTA) Catheter

Device Class : 2

Duns Number: 530923226

Premarket Exempt : No

Product Code : LIT

Prescription Use : No

Device Count : 1

Jade PTA Balloon Dilatation Catheter - 06934955900082 Catalog Number :

Device Description : Percutaneous Transluminal Angioplasty (PTA) Catheter

Device Class : 2

Duns Number: 530923226

Premarket Exempt : No

Product Code : LIT

Prescription Use : No

Device Count : 1

Jade PTA Balloon Dilatation Catheter - 06934955900099 Catalog Number :

Device Description : Percutaneous Transluminal Angioplasty (PTA) Catheter

Device Class : 2

Duns Number: 530923226

Premarket Exempt : No

Product Code : LIT

Prescription Use : No

Device Count : 1

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