MIller Advance Catheter TMI2000

GUDID 10852073002200

Balloon catheter with an insertion sheath for hysterosalpingography and saline infusion sonohysterography

C R I

Intrauterine imaging medium catheter
Primary Device ID10852073002200
NIH Device Record Key24d3697c-399f-455e-86b4-272cb8fe44aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameMIller Advance Catheter
Version Model Number5F HS Catheter
Catalog NumberTMI2000
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

Length21 Centimeter
Length21 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
GS100852073002203 [Primary]
GS110852073002200 [Package]
Contains: 00852073002203
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 Date2016-10-10

On-Brand Devices [MIller Advance Catheter]

10852073002224Balloon catheter with an insertion sheath for hysterosalpingography and saline infusion sonohyst
10852073002217Balloon catheter with an insertion sheath for hysterosalpingography and saline infusion sonohyst
10852073002200Balloon catheter with an insertion sheath for hysterosalpingography and saline infusion sonohyst

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