FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403049873
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
GU4100-012
Catalog number
GU4100-012
Device description
WALTHER DILATOR-CATHETER 12FR FEMALE OVERALL LENGTH 5-3/8"(13.5CM)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10885403049873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540304987310885403049873

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
832696038
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50382909101206Surgiphor9101209101202026-03-05
10885403273780PleurX50-007550-00752017-06-12
10885403075964PleurX50-905050-90502017-06-12
50885403075993Denver42-200042-20002017-06-12
50885403076006Denver42-205542-20552017-06-12
50885403076082Denver42-205042-20502017-06-12
10885403051722V. MuellerHY21305HY213052017-08-11
10885403049408V. MuellerGU4050-008GU4050-0082018-08-30
10885403071263V. MuellerNL1350NL13502018-09-05
10885403105159V. MuellerOS5000-002OS5000-0022018-09-10
20885403473170N/A5513E5513E2019-03-25
50885403142176Wet Exidine448944892018-07-18
50885403142183NA442044202018-07-18
50885403142190NA4461A4461A2018-07-18
50885403142220NA4472A4472A2018-07-18
50885403175211NA443744372018-07-18
50885403184473NA446844682018-07-18
50885403184480NA4469A4469A2018-07-18
50885403192829Scrub Care ExidineCLEAN1CLEAN12018-05-02
10885403465154Snowden-PencerSI325SI3252018-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06936534328683Single Use Urethral DilatorZhejiang Chuangxiang Medical Technology Co., LTD.KOE2023-10-24
16936881102537Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136389Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136396Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136402Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136419Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136426Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136433Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136440Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136457Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136464Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881136471Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
06936881136481Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-12
16936881102513Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10
16936881102520Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10
16936881136495Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10
06936881140716Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10
16944932769882Wellead Urethral DilatorWell Lead Medical Co.,LtdKOE2023-07-10
00856877002728QL Disposable Inflation DeviceATRION MEDICAL PRODUCTS, INC.KOE2022-11-07
08718455508270MED pro Medical B.V.MED pro Medical B.V.KOE2022-09-09