OnPoint Lite System BMT01197-00001

GUDID 00851582006108

OnPoint Lite Visualization System

BIOVISION TECHNOLOGIES, LLC

Endoscopic video imaging system
Primary Device ID00851582006108
NIH Device Record Key8a7e2283-1a3c-4cb6-8986-5ee43ff05efa
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnPoint Lite System
Version Model Number24-4200
Catalog NumberBMT01197-00001
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 Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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 Identifiers

Device Issuing AgencyDevice ID
GS100851582006108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-27

Devices Manufactured by BIOVISION TECHNOLOGIES, LLC

00851582006023 - OnPoint Disposable Scope Kit2018-07-06 OnPoint Disposable Scope with Instruments 1.2mm 0 Degree
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 System2018-07-06OnPoint Lite Visualization System
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.