FDA.reportPublic FDA data

N/A

Primary DI
20705036003912
Brand
N/A
Company
ETHICON ENDO-SURGERY, INC.
Model
OD020
Catalog number
OD020
Device description
Optical Dilator
Published
2016-07-15
Public version status
Update
Distribution status
Not 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
KNQDilator, esophageal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNQDilator, EsophagealGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093236000ETHICON ENDO-SURGERYOPTICAL DILATOREthicon Endo-Surgery, Inc.2009-11-10KNQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705036003919PackageGS114Not in Commercial Distribution
20705036003912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503600391930705036003919
2070503600391220705036003912

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic gastrointestinal stenosis dilatorA sterile invasive device intended to be used to dilate or expand a narrowing lesion (e.g., oesophageal stricture, stenosis) in the lumen of the gastrointestinal [GI] tract, under endoscopic visualization. It is made of transparent synthetic polymer material and is available in various forms (e.g., a slender hollow tube through which is passed the endoscope before introduction into the GI tract, or a tapered cap applied to the distal end of the endoscope); the dilator is advanced through the lesion site with direct visualization through the endoscope. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266customersupport@eesus.jnj.com

Regulatory Flags#

DUNS number
123407392
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705036010180SEDASYSSEDBMU01SEDBMU012014-09-17
10705036010203SEDASYSSEDPRU01SEDPRU012014-09-17
10705036010210SEDASYSSEDPSU01SEDPSU012014-09-17
20705036003554SEDASYSSED8UCSED8UC2014-09-17
20705036003561SEDASYSSEDARM01SEDARM012014-09-17
20705036003578SEDASYSSEDBP6ECSEDBP6EC2016-07-15
20705036003585SEDASYSSEDBPASEDBPA2016-07-15
20705036003592SEDASYSSEDBPALSEDBPAL2016-07-15
20705036003608SEDASYSSEDBPAPSEDBPAP2016-07-15
20705036003615SEDASYSSEDBPSMSEDBPSM2016-07-15
20705036003776SEDASYSSEDE3AMISEDE3AMI2016-07-15
20705036003783SEDASYSSEDECAMISEDECAMI2016-07-15
20705036003806SEDASYSSEDOXECSEDOXEC2016-07-15
20705036003813SEDASYSSEDOXFPSEDOXFP2016-07-15
20705036010224SEDASYSSED15LCDSED15LCD2014-09-17
20705036003899N/AOD016OD0162016-07-15
20705036003905N/AOD018OD0182016-07-15
30705036003896N/AOD016OD0162016-07-15
30705036003902N/AOD018OD0182016-07-15
30705036003919N/AOD020OD0202016-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936937786646STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792364STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792371STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792388STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792395STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792401STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792418STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06936937792425STERIS CleanGuide™Jiangsu Grit Medical Technology Co., Ltd.KNQ2026-07-17
06959664925645NAHangzhou AGS MedTech Co., Ltd.KNQ2026-06-18
06959664925676NAHangzhou AGS MedTech Co., Ltd.KNQ2026-06-18
06959664925584NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925614NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925959NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664925980NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926017NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926048NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926314NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926345NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926376NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926406NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926673NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926703NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926734NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664926765NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927038NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927069NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927090NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927120NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927403NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927434NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15