TMI1185

GUDID 10852073002859

Balloon catheter with an insertion sheath for hysterosalpingography and sonohysterography for use with saline or water-based contrast media

C R I

Intrauterine imaging medium catheter
Primary Device ID10852073002859
NIH Device Record Key0a93ae40-ece5-4c8b-9567-4d36a290cf7d
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5F Shapeable HS Catheter
Catalog NumberTMI1185
Company DUNS130814890
Company NameC R I
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 556-0349
EmailSales@ThomasMedical.com

Device Dimensions

Length28 Centimeter
Length28 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep out of direct sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100852073002852 [Primary]
GS110852073002859 [Package]
Contains: 00852073002852
Package: Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKFCannula, Manipulator/Injector, Uterine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-26

Devices Manufactured by C R I

10852073002361 - NA2020-07-02 Round Loop, Loop Size: 20mm x 13mm
10852073002378 - NA2020-07-02 Round Loop, Loop Size: 20mm x 15mm
10852073002316 - NA2020-06-29 Round Loop, Loop Size: 15mm x 15mm
10852073002484 - NA2020-06-29 Round Loop, Loop Size: 15mm x 10mm
00852073002814 - NA2020-01-21 Balloon catheter with an insertion sheath for hysterosalpingography and sonohysterography for use with saline or water-based con
10852073002231 - NA2019-05-27 Square Loop, Loop Size: 10mm x 4mm
10852073002248 - NA2019-05-27 Round Loop, Loop Size: 5mm x 5mm
10852073002255 - NA2019-05-27 Round Loop, Loop Size: 10mm x 5mm

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