FDA.reportPublic FDA data

uVue

Primary DI
10827002248134
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
OTC
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
042823948
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00827002248137uVueCOOK INCORPORATEDHES2016-09-24
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
00827002303973CookCOOK INCORPORATEDHES2016-09-24
30653405074728CORE DYNAMICSConmed CorporationHES2016-09-24
70885403159956V. MuellerSTERIS CORPORATIONHES2016-09-24
00827002104327MenciniCOOK INCORPORATEDHES2016-09-24