FDA.reportPublic FDA data

EndoSheath Technology

Primary DI
00874485002985
Brand
EndoSheath Technology
Company
COGENTIX MEDICAL, INC.
Model
TV-2.1
Catalog number
03-5101
Device description
EndoSheath Technology for the TNE-5000 Video Esophagoscope
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
EOXEsophagoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOXEsophagoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072088000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072088000FLEXIBLE TRANS-NASAL VIDEO ESOPHAGOSCOPE WITH DIGITAL VIDEO PROCESSOR AND DISPOSABLE ENDOSHEATH SYSTEMSVision-Sciences, Inc.2007-08-29EOX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20874485002996PackageGS110In Commercial Distribution
00874485002985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2087448500299620874485002996
00874485002985008744850029858744850029850874485002985

GMDN Terms#

Term, Definition table
TermDefinition
Optical medical device procedural coverA device designed to fit over the distal end of a 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 direct contact to the eye and/or cross-contamination between patients; it is not intended to act as a spacer. It is typically a small rigid partially- or fully- transparent plastic device. This is a single-use device.

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
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
00874485003142EndoSheath TechnologyCF-2.108-41012016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04961333251766PENTAX MedicalHOYA CORPORATIONEOX2023-06-21
00860008795557EsoCheck CCD Cell Collection DeviceLucid Diagnostics IncEOX2023-01-26
04048551417348n.a.Karl Storz GmbH & Co. KGEOX2020-03-02
00860002356006EsoCheck CCD Cell Collection DeviceLucid Diagnostics IncEOX2019-12-17
00874485003210UNITY 9100COGENTIX MEDICAL, INC.EOX2018-12-20
04048551178515n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551178539n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551178546n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190098n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190104n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
04048551190111n.a.Karl Storz GmbH & Co. KGEOX2018-07-21
00874485003005EndoSheath TechnologyCOGENTIX MEDICAL, INC.EOX2016-09-23
04048551001387n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551001493n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551001974n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047675n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047811n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047828n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047866n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047873n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047897n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047903n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047941n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047989n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551047996n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551048641n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551048658n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551053591n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551068762n.a.Karl Storz GmbH & Co. KGEOX2016-09-23
04048551068786n.a.Karl Storz GmbH & Co. KGEOX2016-09-23