FDA.reportPublic FDA data

NeedleCam HD System

Primary DI
00851582006047
Brand
NeedleCam HD System
Company
BIOVISION TECHNOLOGIES, LLC
Model
BVT01197-00001
Catalog number
BVT01197-00001
Device description
NeedleCam HD 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
00851582006047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851582006047008515820060478515820060470851582006047

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

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
00851582006085InnerVue II 100mm Scope Kit922142BVTKIT72-1R2A02016-06-17
008515820060921.2mm InnerVue II Scope Kit922180BVTKIT72-1R2652016-09-27
00851582006108OnPoint Lite System24-4200BMT01197-000012016-09-27
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
00190776425883MillenniumAvalign Technologies, Inc.GCJ2026-08-18
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00190776425975MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426361MillenniumAvalign Technologies, Inc.GCJ2026-08-18
00190776426378MillenniumAvalign Technologies, Inc.GCJ2026-08-18
10850013527936DANNIKDannik LLCGCJ2026-08-17
108500135279817mm XL SUPERBAGDannik LLCGCJ2026-08-17
00889095731972ALVUEGLOBUS MEDICAL, INC.GCJ2026-08-14
00889095731989ALVUEGLOBUS MEDICAL, INC.GCJ2026-08-14
00190776423605MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776423650MillenniumAvalign Technologies, Inc.GCJ2026-08-07
00190776423667MillenniumAvalign Technologies, Inc.GCJ2026-08-07
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00190776422745MillenniumAvalign Technologies, Inc.GCJ2026-08-03
00190776422752MillenniumAvalign Technologies, Inc.GCJ2026-08-03
04026704934812TELEFLEXTELEFLEX INCORPORATEDGCJ2026-08-03
B382SD4131490Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD4162910Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD49245120Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD55670280Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56325330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56400150Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56534210Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD567910130Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
B382SD56914330Surgical DirectSurgical Direct, Inc.GCJ2026-08-03
00190776421960MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00190776422325MillenniumAvalign Technologies, Inc.GCJ2026-07-31
00888867498105Arthrex®ARTHREX, INC.GCJ2026-07-31
14026704921741TELEFLEXTELEFLEX INCORPORATEDGCJ2026-07-31