HYDROCISION, INC.

HYDROCISION, INC.

Address:267 Boston Road,BILLERICA,MA,01862,US

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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) (9)

Premarket Exempt

No

Clear

TenJet® - 00853235007005 Catalog Number : 76000

Device Description : TenJet® Percutaneous Hydrotenotomy Set

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

TenJet® - 00853235007012 Catalog Number : 76400

Device Description : TenJet® Accessory Set

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

TenJet® - 00853235007029 Catalog Number : 76700

Device Description : TenJet® Percutaneous Hydrotenotomy Set

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

SpineJet® - 00853235007036 Catalog Number : 52320

Device Description : SpineJet® MicroResector

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

HydroCision Console - 00853235007043 Catalog Number : 52700

Device Description : HydroCision Console

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

SpineJet® - 00853235007050 Catalog Number : 55500

Device Description : SpineJet® Quick Connector

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

SpineJet® - 00853235007067 Catalog Number : 56000

Device Description : SpineJet® Percutaneous Hydrodiscectomy Set with Access Set

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

SpineJet® - 00853235007074 Catalog Number : 56110

Device Description : SpineJet® EndoResector

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

SpineJet® - 00853235007081 Catalog Number : 56971

Device Description : SpineJet® Microdisectomy Access Set

Device Class :

Duns Number: 834612764

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

SpineJet® - 00853235007098 Catalog Number : 56986

Device Description : SpineJet® Percutaneous Access straight Set-Diposable

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

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