FDA.reportPublic FDA data

Olympus

Primary DI
00821925033214
Brand
Olympus
Company
Gyrus ACMI, LLC
Model
BD-400P-2080
Device description
EZDilate - Fixed Wire Esophageal 3-Stage Balloon Dilatation Catheter 18-20mm
Published
2016-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KNQDilator, esophageal

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925033214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925033214008219250332148219250332140821925033214

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal balloon catheterA long, flexible device with an inflatable balloon(s) at its distal end designed to access the length of the oesophagus of adult and adolescent patients to dilate strictures through balloon inflation. It is typically constructed as a catheter of various designs and is usually used endoscopically to enable visualization during the procedure. It is typically used to dilate strictures due to oesophageal surgery, primary gastric reflux, radiation therapy, and dilatation of the cardia in patients with achalasia (failure to relax the lower oesophageal sphincter). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007198742
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

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