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) (10)

Premarket Exempt

Clear

SpineJet® - 00853235007203 Catalog Number : 59961

Device Description : SpineJet® -10° DL Pull

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

SpineJet® - 00853235007210 Catalog Number : 59971

Device Description : SpineJet® +10° DL Push

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

Knob - 00853235007227 Catalog Number : 51705

Device Description : KNOB, DILATOR, CANNULA SET - FINAL ASSY.

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

Trephine - 00853235007234 Catalog Number : 51711

Device Description : Trephine, Extended, Cannula Set - Final Assy

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

SpineJet® - 00853235007241 Catalog Number : 51739

Device Description : SpineJet® Access Set, 8" Needle

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

SpineJet® - 00853235007258 Catalog Number : 51740

Device Description : SpineJet® 4.0 Percutaneous Access Set, 7.5" Dilator

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

Cannula - 00853235007265 Catalog Number : 57165

Device Description : CANNULA, .157 O.D., .137 I.D., CANNULA SET

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

SpineJet® - 00853235007272 Catalog Number : 51786

Device Description : SpineJet® Access Set, Instrument Tray

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

SpineJet® - 00853235007289 Catalog Number : 52005

Device Description : SpineJet® Microdiscectomy Access Set, 4.0 Cannula

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

QuickKart Procedure Cart - 00853235007296 Catalog Number : 50300

Device Description : QuickKart Procedure Cart

Device Class : 2

Duns Number: 834612764

Premarket Exempt : No

Product Code : HRX

Prescription Use : No

Device Count : 1

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