OnPoint Disposable Scope Kit BVTKIT72-0L065

GUDID 00851582006023

OnPoint Disposable Scope with Instruments 1.2mm 0 Degree

BIOVISION TECHNOLOGIES, LLC

Endoscopic video imaging system
Primary Device ID00851582006023
NIH Device Record Key1c039de7-9b04-4e1e-a51e-6ca622bed6e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnPoint Disposable Scope Kit
Version Model Number24-3000
Catalog NumberBVTKIT72-0L065
Company DUNS166160106
Company NameBIOVISION TECHNOLOGIES, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone303-237-9608
Emailbray@biovisiontech.com

Device Dimensions

Outer Diameter1.2 Millimeter
Outer Diameter1.2 Millimeter
Outer Diameter1.2 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100851582006023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-17

Devices Manufactured by BIOVISION TECHNOLOGIES, LLC

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00851582006047 - NeedleCam HD System2018-07-06 NeedleCam HD Visualization System
00851582006085 - InnerVue II 100mm Scope Kit2018-07-06 1.2mm Disposable InnerVue II Scope with Accessories 100mm WL, 10 Degree
00851582006092 - 1.2mm InnerVue II Scope Kit2018-07-06 1.2mm Disposable InnerVue II Scope with Accessories 65mm W.L., 10 Degree
00851582006108 - OnPoint Lite System2018-07-06 OnPoint Lite Visualization System
00851582006122 - NeedleView 0 Degree 65mm Scope Kit2018-07-06 1.2mm NeedleView 0 Degree 65mm Scope Kit
00851582006139 - NeedleView 0 Degree 100mm Scope Kit2018-07-06 1.2mm NeedleView 0 Degree 100mm Scope Kit
00851582006146 - NeedleView 10 Degree 65mm Scope Kit2018-07-06 1.2mm NeedleView 10 Degree 65mm Scope Kit

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