MIller Advance Catheter TMI2001

GUDID 10852073002217

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

C R I

Intrauterine imaging medium catheter
Primary Device ID10852073002217
NIH Device Record Key72142c3a-75f8-4caf-a8ec-a48c83c10dec
Commercial Distribution StatusIn Commercial Distribution
Brand NameMIller Advance Catheter
Version Model Number5F HS Catheter
Catalog NumberTMI2001
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

Catheter Gauge5 French
Catheter Gauge5 French

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100852073002210 [Primary]
GS110852073002217 [Package]
Contains: 00852073002210
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 Date2016-10-11

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.