FDA.reportPublic FDA data

N/A

Primary DI
30705036003919
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
123407392
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
20705036003912N/AOD020OD0202016-07-15
30705036003896N/AOD016OD0162016-07-15
30705036003902N/AOD018OD0182016-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06959664927465NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664927496NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664928943NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664928974NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664929001NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664929032NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664929070NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15
06959664929100NAHangzhou AGS MedTech Co., Ltd.KNQ2026-04-15