FDA.reportPublic FDA data

EZDilate

Primary DI
00821925033092
Brand
EZDilate
Company
Gyrus ACMI, LLC
Model
BURS0504K
Device description
Uro-EZDilate KIT 15Fr (5mm) x 4cm URETERAL BALLOON DILATION CATHETER AND INFLATION DEVICE
Published
2016-10-05
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
KOEDILATOR, URETHRAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOEDilator, UrethralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132181000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132181000GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETEROlympus Surgical Technologies America2013-10-21EZN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925033092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925033092008219250330928219250330920821925033092

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral dilatation catheterA flexible tube designed to be inserted into the ureters exclusively to increase the ureteral lumen by eliminating areas of narrowing (i.e., strictures). It is typically made of plastic and may have a special tip (e.g., olive) or an inflatable hydraulic balloon at its tip for dilating. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925013964GYRUS ACMI, INC1400032015-10-24
00821925014039EVONOS GMBH & Co. Kg1400532015-10-24
00821925014060EVONOS GMBH & Co. Kg1400592015-10-24
00821925014176GYRUS ACMI, INC1400872015-10-24
00821925014190GYRUS ACMI, INC1401022015-10-24
00821925014497GYRUS ACMI, INC1401032015-10-24
00821925014534GYRUS ACMI, INC1400702015-10-24
00821925015449Gyrus ACMI1401812015-10-24
00821925015470Gyrus ACMI1401852015-10-24
00821925015487Gyrus ACMI1401862015-10-24
00821925015500GYRUS ACMI, INC1401882015-10-24
00821925016057Gyrus ACMI1401642015-10-24
00821925016064Gyrus ACMI1401652015-10-24
00821925016071Gyrus ACMI1401662015-10-24
00821925016088Gyrus ACMI1401672015-10-24
00821925016095GYRUS ACMI, INC1401682015-10-24
00821925016125Gyrus ACMI1401802015-10-24
00821925016934GYRUS ACMI, INC1401492015-10-24
00821925016965Gyrus ACMI1401622015-10-24
00821925017207GYRUS ACMI, INC1401082015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856877002780Everis, Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2026-05-20
06976358503538SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503545SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503552SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503569SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503576SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
06976358503583SEPLOUSEPLOU (ZHUHAI) CO.,LTD.KOE2026-05-14
10840217910009Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
20840217910006Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
00840217910002Ace Medical CompanyEbner Medical, LLCKOE2025-10-07
00853095008341Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008358Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008365Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008372Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008389Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00853095008396Optilume Basic Urological Dilation catheterUrotronic, Inc.KOE2025-07-18
00856877002759QL Disposable Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2025-05-16
00856877002766Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2025-05-16
00856877002773Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2025-05-16
00856877002704Atrion QL4515 Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2024-08-06
00856877002735QL Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2024-08-06
06936534328683Single Use Urethral DilatorZhejiang Chuangxiang Medical Technology Co., LTD.KOE2023-10-24
06936881102530Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136382Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136399Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136405Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136412Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136429Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136436Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136443Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12