FDA.reportPublic FDA data

EndoSheath Technology

Primary DI
00874485003159
Brand
EndoSheath Technology
Company
COGENTIX MEDICAL, INC.
Model
CF-1.5
Catalog number
08-4102
Device description
EndoSheath Technology for CST-4000 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
HIHHysteroscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071127000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071127000FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEMVision-Sciences, Inc.2007-11-16HIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20874485001302PackageGS110In Commercial Distribution
00874485003159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2087448500130220874485001302
00874485003159008744850031598744850031590874485003159

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
07613327616675SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616682SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616699SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616705SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616712SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616729SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616736SPYSTRYKER CORPORATIONHIH2024-02-27
07613327616743SPYSTRYKER CORPORATIONHIH2024-02-27
07613327624311NASTRYKER CORPORATIONHIH2024-02-27
07613327507102N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507119N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507126N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507133N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
07613327507140N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.HIH2020-10-26
14042761085172OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085189OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085196OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085202OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085219OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085226OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085233OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085240OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085257OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085264OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085271OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085288OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085295OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085301OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085318OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31
14042761085325OlympusOLYMPUS Winter & Ibe GmbHHIH2020-07-31