RELIGN CORPORATION

Address:655 Campbell Technology Parkway, Ste 275,Campbell,CA,95008,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) Electrosurgical, Cutting & Coagulation & Accessories (GEI) (10)

Premarket Exempt

Clear

Tricera™ Controller - 00859273007014 Catalog Number : R-10001

Device Description : System Controller with Footswitch

Device Class : 2

Duns Number: 080031617

Premarket Exempt : No

Product Code : HRX, GEI

Prescription Use : Yes

Device Count : 1

Tricera™ Handpiece - 00859273007021 Catalog Number : R-10002

Device Description : Shaver Handpiece

Device Class : 2

Duns Number: 080031617

Premarket Exempt : No

Product Code : HRX, GEI

Prescription Use : Yes

Device Count : 1

Veriflow™ - 00859273007038 Catalog Number : R-10003

Device Description : Fluid management accessory disposable

Device Class :

Duns Number: 080031617

Premarket Exempt : No

Product Code : HRX, GEI

Prescription Use : Yes

Device Count : 1

Dynablator™ - 00859273007052 Catalog Number : R-10005

Device Description : RF probe, disposable

Device Class : 2

Duns Number: 080031617

Premarket Exempt : No

Product Code : GEI, HRX

Prescription Use : Yes

Device Count : 1

3-in-1 SHAVER™ 4.2mm - 00859273007083 Catalog Number : R-10008

Device Description : Multi-functional shaver blade, disposable

Device Class : 2

Duns Number: 080031617

Premarket Exempt : No

Product Code : HRX, GEI

Prescription Use : Yes

Device Count : 1

Tricera™ Handpiece, Autoclavable - 00859273007113 Catalog Number : R-10011

Device Description : Shaver Handpiece, Autoclavable

Device Class : 2

Duns Number: 080031617

Premarket Exempt : No

Product Code : GEI, HRX

Prescription Use : Yes

Device Count : 1

Standard Shaver 3.4mm - 00859273007120 Catalog Number : R-10012

Device Description : Standard shaver blade, disposable

Device Class : 2

Duns Number: 080031617

Premarket Exempt : No

Product Code : HRX, GEI

Prescription Use : Yes

Device Count : 1

3-in-1 SHAVER™ 5.0mm - 00859273007144 Catalog Number : R-10014

Device Description : Multi-functional shaver blade, disposable

Device Class : 2

Duns Number: 080031617

Premarket Exempt : No

Product Code : HRX, GEI

Prescription Use : Yes

Device Count : 1

Exoflow™ - 00859273007175 Catalog Number : R-10017

Device Description : Fluid management accessory disposable, outflow only

Device Class : 2

Duns Number: 080031617

Premarket Exempt : No

Product Code : GEI, HRX

Prescription Use : Yes

Device Count : 1

Standard Burr 5.0mm - 00859273007212 Catalog Number : R-10021

Device Description : Standard burr, disposable

Device Class :

Duns Number: 080031617

Premarket Exempt : No

Product Code : HRX, GEI

Prescription Use : Yes

Device Count : 1

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