FDA.reportPublic FDA data

NeedleView 10 Degree 100mm Scope Kit

Primary DI
00851582006153
Brand
NeedleView 10 Degree 100mm Scope Kit
Company
BIOVISION TECHNOLOGIES, LLC
Model
BVTKIT72-1R1A0
Catalog number
BVTKIT72-1R1A0
Device description
1.2mm NeedleView `0 Degree 100mm Scope Kit
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082293000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082293000SURGVIEW INTEGRATED VISUALIZATION SYSTEMBiovision Technologies, LLC2008-09-09HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851582006153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851582006153008515820061538515820061530851582006153

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle10degree
Length100Millimeter
Outer Diameter1.2Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
303-237-9608bray@biovisiontech.com

Regulatory Flags#

DUNS number
166160106
Device count
1
Lot or batch
true
Expiration date on label
true

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
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
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

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