BIOVISION TECHNOLOGIES, LLC

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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

Laparoscope, General & Plastic Surgery (GCJ) (10) Arthroscope (HRX) (8)

Premarket Exempt

Clear

OnPoint Disposable Scope Kit - 00851582006023 Catalog Number : BVTKIT72-0L065

Device Description : OnPoint Disposable Scope with Instruments 1.2mm 0 Degree

Device Class : 2

Duns Number: 166160106

Premarket Exempt : No

Product Code : GCJ, HRX

Prescription Use : Yes

Device Count : 1

NeedleView CH Scope Kit - 00851582006030 Catalog Number : BVTKIT82-34001

Device Description : 3.4mm Disposable NeedleView CH Scope with Accessories

Device Class : 2

Duns Number: 166160106

Premarket Exempt : No

Product Code : GCJ, HRX

Prescription Use : Yes

Device Count : 1

NeedleCam HD System - 00851582006047 Catalog Number : BVT01197-00001

Device Description : NeedleCam HD Visualization System

Device Class : 2

Duns Number: 166160106

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

InnerVue II 100mm Scope Kit - 00851582006085 Catalog Number : BVTKIT72-1R2A0

Device Description : 1.2mm Disposable InnerVue II Scope with Accessories 100mm WL, 10 Degree

Device Class : 2

Duns Number: 166160106

Premarket Exempt : No

Product Code : HRX, GCJ

Prescription Use : Yes

Device Count : 1

1.2mm InnerVue II Scope Kit - 00851582006092 Catalog Number : BVTKIT72-1R265

Device Description : 1.2mm Disposable InnerVue II Scope with Accessories 65mm W.L., 10 Degree

Device Class : 2

Duns Number: 166160106

Premarket Exempt : No

Product Code : GCJ, HRX

Prescription Use : Yes

Device Count : 1

OnPoint Lite System - 00851582006108 Catalog Number : BMT01197-00001

Device Description : OnPoint Lite Visualization System

Device Class : 2

Duns Number: 166160106

Premarket Exempt : No

Product Code : GCJ

Prescription Use : Yes

Device Count : 1

NeedleView 0 Degree 65mm Scope Kit - 00851582006122 Catalog Number : BVTKIT72-0L165

Device Description : 1.2mm NeedleView 0 Degree 65mm Scope Kit

Device Class : 2

Duns Number: 166160106

Premarket Exempt : No

Product Code : GCJ, HRX

Prescription Use : Yes

Device Count : 1

NeedleView 0 Degree 100mm Scope Kit - 00851582006139 Catalog Number : BVTKIT72-0L1A0

Device Description : 1.2mm NeedleView 0 Degree 100mm Scope Kit

Device Class : 2

Duns Number: 166160106

Premarket Exempt : No

Product Code : GCJ, HRX

Prescription Use : Yes

Device Count : 1

NeedleView 10 Degree 65mm Scope Kit - 00851582006146 Catalog Number : BVTKIT72-1R165

Device Description : 1.2mm NeedleView 10 Degree 65mm Scope Kit

Device Class : 2

Duns Number: 166160106

Premarket Exempt : No

Product Code : GCJ, HRX

Prescription Use : Yes

Device Count : 1

NeedleView 10 Degree 100mm Scope Kit - 00851582006153 Catalog Number : BVTKIT72-1R1A0

Device Description : 1.2mm NeedleView `0 Degree 100mm Scope Kit

Device Class : 2

Duns Number: 166160106

Premarket Exempt : No

Product Code : GCJ, HRX

Prescription Use : Yes

Device Count : 1

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