FDA.reportPublic FDA data

EndoSheath Technology

Primary DI
00874485003173
Brand
EndoSheath Technology
Company
COGENTIX MEDICAL, INC.
Model
CV-1.5
Catalog number
08-5102
Device description
EndoSheath Technology for the CST-5000 Cystoscope
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FAJCystoscope And Accessories, Flexible/Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072180000VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEMVision-Sciences, Inc.2007-12-18FAJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20874485000820PackageGS110In Commercial Distribution
20874485000824PackageGS110In Commercial Distribution
00874485003173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2087448500082020874485000820
2087448500082420874485000824
00874485003173008744850031738744850031730874485003173

GMDN Terms#

Term, Definition table
TermDefinition
Optical medical device procedural coverA device designed to fit over the distal end of a hand-held, non-surgically-invasive device with optical functionality (e.g., laser beam-guide, optical scanning handpiece, endoscope) during use to act as a cover/shield to avoid cross-contamination between patients; it is not intended to act as a spacer. It is typically a small rigid plastic device which includes a transparent window. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-258-2182customercare@cogentixmedical.com

Regulatory Flags#

DUNS number
780024725
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00874485003180Endoscopic Cytology Brush07-90012016-09-23
00874485003197Nasal Cytology Brush07-90062016-09-23
00874485000844Flexible Video Esophagoscope (NTSC)TNE-500003-52012016-09-22
00874485002367Flexible Video Bronchoscope (NTSC)BRS-510004-52032016-09-22
00874485002848Flexible Video Bronchoscope (NTSC) ReconditionedBRS-510004-5203P2016-09-22
00874485002879Flexible Video Esophagoscope (NTSC) ReconditionedTNE-500003-5201P2016-09-22
00874485000318Portable LED Light SourceBLS-100007-30502016-09-23
00874485002985EndoSheath TechnologyTV-2.103-51012016-09-23
00874485003005EndoSheath TechnologyTV-1.503-51022016-09-23
00874485003029EndoSheath TechnologyBF-2.104-41012016-09-23
00874485003036EndoSheath TechnologyBF-1.504-41022016-09-23
00874485003043EndoSheath TechnologyBF-2.804-41032016-09-23
00874485003050EndoSheath TechnologyBF-004-41052016-09-23
00874485003067EndoSheath TechnologyBV-2.104-51012016-09-23
00874485003074EndoSheath TechnologyBV-1.504-51022016-09-23
00874485003098EndoSheath TechnologyBV-004-51052016-09-23
00874485003104EndoSheath TechnologyBVX-2.104-51112016-09-23
00874485003111EndoSheath TechnologyBVX-1.504-51122016-09-23
00874485003128EndoSheath TechnologyBVX-2.804-51132016-09-23
00874485003135EndoSheath TechnologyBVX-004-51152016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826926952PENTAX MedicalPENTAX MEDICAL CORPORATIONFAJ2026-08-25
06975339621506BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621513BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621520BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621537BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621926BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621933BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621964BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
06975339621971BubbleViewMacroLux Medical Technology Co., Ltd.FAJ2026-08-14
00850023925442WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925459WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925466WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925473WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925558WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925565WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925572WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925589WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925596WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925909WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925916WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925923WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925930WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925954WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925985WiScope®Otu Medical Inc.FAJ2026-07-28
00850023925992WiScope®Otu Medical Inc.FAJ2026-07-28
06972084140498WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140504WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140511WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140528WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140597WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28