FDA.reportPublic FDA data

N/A

Primary DI
30705036003902
Brand
N/A
Company
ETHICON ENDO-SURGERY, INC.
Model
OD018
Catalog number
OD018
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
30705036003902PackageGS114Not in Commercial Distribution
20705036003905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503600390230705036003902
2070503600390520705036003905

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
30705036003919N/AOD020OD0202016-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10653405050865CONMEDConmed CorporationKNQ2026-03-24
46932503524016Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524023Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524030Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524047Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524054Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524061Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524078ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524085ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524092ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524108ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524122ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524146ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
46932503524153ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
00724995244576LumiflexUS EndoscopyKNQ2025-06-03
00724995244606LumiflexUS EndoscopyKNQ2025-06-03
00724995244620LumiflexUS EndoscopyKNQ2025-06-03
00724995244637LumiflexUS EndoscopyKNQ2025-06-03
00724995244651LumiflexUS EndoscopyKNQ2025-06-03
00724995244699LumiflexUS EndoscopyKNQ2025-06-03
00724995244705LumiflexUS EndoscopyKNQ2025-06-03
00724995244712LumiflexUS EndoscopyKNQ2025-06-03
20653405050787CONMEDConmed CorporationKNQ2023-10-10
04260206311386BougieCapOvesco Endoscopy AGKNQ2022-09-30
04260206311409BougieCapOvesco Endoscopy AGKNQ2022-09-30
04260206311423BougieCapOvesco Endoscopy AGKNQ2022-09-30
04260206311447BougieCapOvesco Endoscopy AGKNQ2022-09-30
04260206311461BougieCapOvesco Endoscopy AGKNQ2022-09-30
04260206311485BougieCapOvesco Endoscopy AGKNQ2022-09-30
00884450383438Elation 5™Merit Medical Systems, Inc.KNQ2022-08-25