FDA.reportPublic FDA data

OnPoint Lite System

Primary DI
00851582006108
Brand
OnPoint Lite System
Company
BIOVISION TECHNOLOGIES, LLC
Model
24-4200
Catalog number
BMT01197-00001
Device description
OnPoint Lite Visualization System
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143705000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143705000NeedleCam HD Visualization SystemBiovision Technologies, LLC2015-02-20HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851582006108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851582006108008515820061088515820061080851582006108

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video imaging systemAn assembly of mains electricity (AC-powered) devices designed to obtain, transmit, and display video images during an endoscopic procedure. It typically consists of one or more video endoscopes, an endoscopic camera, camera control unit, light source with light cables, video recorder, imaging units with perhaps a colour compensation device, a distention unit, and a visual display unit (VDU), all of which is typically placed/mounted onto a trolley (cart) that can be moved to different examination/treatment rooms.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
303-237-9608bray@biovisiontech.com
904-741-4400fxjax-orders@biomet.com

Regulatory Flags#

DUNS number
166160106
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851582006023OnPoint Disposable Scope Kit24-3000BVTKIT72-0L0652016-06-17
00851582006047NeedleCam HD SystemBVT01197-00001BVT01197-000012016-09-27
00851582006085InnerVue II 100mm Scope Kit922142BVTKIT72-1R2A02016-06-17
008515820060921.2mm InnerVue II Scope Kit922180BVTKIT72-1R2652016-09-27
00851582006122NeedleView 0 Degree 65mm Scope KitBVTKIT72-0L165BVTKIT72-0L1652016-09-27
00851582006139NeedleView 0 Degree 100mm Scope KitBVTKIT72-0L1A0BVTKIT72-0L1A02016-09-27
00851582006146NeedleView 10 Degree 65mm Scope KitBVTKIT72-1R165BVTKIT72-1R1652016-09-27
00851582006153NeedleView 10 Degree 100mm Scope KitBVTKIT72-1R1A0BVTKIT72-1R1A02016-09-27
00851582006160NeedleView 30 Degree 65mm Scope KitBVTKIT75-3R165BVTKIT75-3R1652016-09-27
00851582006177NeedleView 30 Degree 100mm Scope KitBVTKIT75-3R1A0BVTKIT75-3R1A02016-09-27
00851582006030NeedleView CH Scope KitBVTKIT82-34001BVTKIT82-340012016-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427931MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428051MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776428303MillenniumAvalign Technologies, Inc.GCJ2026-08-27
00190776427429MillenniumAvalign Technologies, Inc.GCJ2026-08-26
04580826928451PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928543PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928581PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
04580826928604PENTAX MedicalPENTAX MEDICAL CORPORATIONGCJ2026-08-25
08800035701499CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701505CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701512CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701529CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701536CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701543CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701949CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701956CORE-TrocarINCORE CO., LTDGCJ2026-08-25
08800035701963CORE-TrocarINCORE CO., LTDGCJ2026-08-25
B382SD13448970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD16008970Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD161730Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205052000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205082000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD7720508TS2000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
B382SD77205252000Surgical DirectSurgical Direct, Inc.GCJ2026-08-21
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425906MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425968MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18