FDA.reportPublic FDA data

Single Use Urethral Dilator

Primary DI
06936534328683
Brand
Single Use Urethral Dilator
Company
Zhejiang Chuangxiang Medical Technology Co., LTD.
Model
MD-S-UD-0840
Published
2023-10-24
Public version status
New
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936534328683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936534328683069365343286836936534328683

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic-access dilator, single-useA device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544434963
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
06970401812110Single Use Grasping ForcepsMD-C-GF18062023-02-07
06970401813490Single Use GuidewireMD-S-GW35452019-03-23
06970401813766Single Use GuidewireMD-A-GW35452021-09-27
06970401815661Single Use GuidewireMD-S-GW25452020-06-17
06936534325439Single Use Urinary GuidewireMD-A1-UW21182023-11-27
06936534325446Single Use Urinary GuidewireMD-A1-UW21202023-11-27
06936534325453Single Use Urinary GuidewireMD-A1-UW21262023-11-27
06936534325460Single Use Urinary GuidewireMD-A1-UW25052023-11-27
06936534325477Single Use Urinary GuidewireMD-A1-UW25102023-11-27
06936534325484Single Use Urinary GuidewireMD-A1-UW25122023-11-27
06936534325491Single Use Urinary GuidewireMD-A1-UW25152023-11-27
06936534325507Single Use Urinary GuidewireMD-A1-UW25182023-11-27
06936534325514Single Use Urinary GuidewireMD-A1-UW25202023-11-27
06936534325521Single Use Urinary GuidewireMD-A1-UW25262023-11-27
06936534325538Single Use Urinary GuidewireMD-A1-UW28052023-11-27
06936534325545Single Use Urinary GuidewireMD-A1-UW28102023-11-27
06936534325552Single Use Urinary GuidewireMD-A1-UW28122023-11-27
06936534325569Single Use Urinary GuidewireMD-A1-UW28152023-11-27
06936534325576Single Use Urinary GuidewireMD-A1-UW28182023-11-27
06936534325583Single Use Urinary GuidewireMD-A1-UW28202023-11-27

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
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
06936881136450Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12