FDA.reportPublic FDA data

uVue

Primary DI
00827002248137
Brand
uVue
Company
COOK INCORPORATED
Model
G24813
Catalog number
J-UHSG-062026
Device description
uVue HSG/SHG Catheter
Published
2016-09-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HESINSUFFLATOR, CARBON-DIOXIDE, UTEROTUBAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HESInsufflator, Carbon-Dioxide, Uterotubal (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002248134PackageGS110In Commercial Distribution
00827002248137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1082700224813410827002248134
00827002248137008270022481378270022481370827002248137

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine imaging medium catheterA flexible tube designed for the intrauterine injection of an opaque tracer medium, to facilitate radiography of the fallopian tubes/uterus (salpingography/ hysterosalpingography), and/or a saline solution, to enhance transvaginal ultrasonography (TVUS) [saline infused sonography (SIS)/ hysterosonography]. It is typically a duel lumen tube, with a non-latex inflatable cuff (balloon), pad or cap near the distal tip intended to seal the cervix, and may include devices dedicated to catheter function (e.g., stylet, syringe). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002000766CookG00076MDC-62020-10-02
00827002000773CookG00077MDC-72020-10-02
00827002000780CookG00078MDC-82020-10-02
00827002009653CookG00965MDC-102020-10-02
00827002009660CookG00966MDC-52020-10-02
00827002010796CookG01079MDC-92020-10-02
00827002013209CookG01320MDC-122020-10-02
00827002014626CookG01462MDC-142020-10-02
00827002016170CookG01617MDC-162020-10-02
00827002026896CookG02689MDC-42020-10-02
00827002027350CookG02735MDC-32020-10-02
00827002048881CookG04888FD-1002020-10-02
00827002541900GuardiaG54190J-UOB-40282016-09-24
00827002541917GuardiaG54191J-UOB-4028-ST2016-09-24
00827002614994MagniCoreG61499MRCHN-20-15.02026-03-27
00827002615007MagniCoreG61500MRCHN-18-10.02026-03-27
00827002615014MagniCoreG61501MRCHN-18-15.02026-03-27
00827002615021MagniCoreG61502MRCHN-18-20.02026-03-27
00827002615038MagniCoreG61503MRCHN-20-10.02026-03-27
00827002615045MagniCoreG61504MRCHN-20-20.02026-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055270966148RocketROCKET MEDICAL PLCHES2023-10-31
05055270974440RocketROCKET MEDICAL PLCHES2023-10-31
05055270966155RocketROCKET MEDICAL PLCHES2023-10-31
05055270974457RocketROCKET MEDICAL PLCHES2023-10-31
05055270981370RocketROCKET MEDICAL PLCHES2023-10-24
05055270981387RocketROCKET MEDICAL PLCHES2023-10-24
00887517021472PRECICE® Plating SystemNUVASIVE SPECIALIZED ORTHOPEDICS, INC.HES2020-01-06
00888937015805Kronner ManipujectorCoopersurgical, Inc.HES2019-01-31
20888937014765Kronner ManipujectorCoopersurgical, Inc.HES2019-01-31
00827002303683CookCOOK INCORPORATEDHES2016-11-04
10653405045465CORE DYNAMICSConmed CorporationHES2016-09-24
10653405045472CORE DYNAMICSConmed CorporationHES2016-09-24
10885403045080V. MuellerSTERIS CORPORATIONHES2016-09-24
10885403045097V. MuellerSTERIS CORPORATIONHES2016-09-24
10885403045110V. MuellerSTERIS CORPORATIONHES2016-09-24
10885403045127V. MuellerSTERIS CORPORATIONHES2016-09-24
10885403050084V. MuellerSTERIS CORPORATIONHES2016-09-24
20653405045479CORE DYNAMICSConmed CorporationHES2016-09-24
10885403045134V. MuellerCAREFUSION 2200, INCHES2016-09-24
00827002165755SholkoffCOOK INCORPORATEDHES2016-09-24
10827002171470CookCOOK INCORPORATEDHES2016-09-24
10827002174716CookCOOK INCORPORATEDHES2016-09-24
10827002174723CookCOOK INCORPORATEDHES2016-09-24
00827002175907CookCOOK INCORPORATEDHES2016-09-24
10827002178707CookCOOK INCORPORATEDHES2016-09-24
10827002248134uVueCOOK INCORPORATEDHES2016-09-24
00827002303973CookCOOK INCORPORATEDHES2016-09-24
30653405074728CORE DYNAMICSConmed CorporationHES2016-09-24
70885403159956V. MuellerSTERIS CORPORATIONHES2016-09-24
00827002104327MenciniCOOK INCORPORATEDHES2016-09-24