FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403049958
Brand
V. Mueller
Company
STERIS CORPORATION
Model
GU4100-028
Catalog number
GU4100028
Device description
V. Mueller WALTHER DILATOR-CATHETER 28FR FEMALE OVERALL LENGTH 5-5/8 inches 14.5CM
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
10885403049958PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540304995810885403049958

GMDN Terms#

Term, Definition table
TermDefinition
Urethral dilator, reusableA slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088gmb-MedSpec-CustService@carefusion.com
+1(800)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
10724995165250NAX-Ray Table TopBF6632021-04-02
10724995165281NAX-Ray Table TopBF6642021-04-02
10724995245457HexaLuxEXLHAN3EXLHAN32025-05-05
00724995165161NAX-Ray Table TopBF5532021-04-02
00724995165178NATable ExtenderBF5552021-04-02
00724995165185NAX-Ray Table TopBF5542021-04-02
00724995165222NAX-Ray Table TopBF6622021-04-02
10885403018862V. MuellerCD0-3BCD03B2017-11-17
10885403018879V. MuellerCD0-3CCD03C2017-11-17
10885403018893V. MuellerCD0-4BCD04B2017-11-17
10885403018909V. MuellerCD0-4CCD04C2017-11-17
10885403018947V. MuellerCD1-4BCD14B2017-11-17
10885403018954V. MuellerCD1-4CCD14C2017-11-17
10885403018985V. MuellerCD1-5BCD15B2017-11-17

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