Flex-Ez Over the Wire Balloon Dilator 3210

GUDID M84932100

A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically dilate gastrointestinal strictures. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen with radiopaque markers and is wire-guided. This is a single-use device.

HOBBS MEDICAL, INC.

Gastrointestinal/biliary dilation balloon catheter, non-medicated
Primary Device IDM84932100
NIH Device Record Key38b1e5a4-0972-4267-b3e9-0f4821f5940f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlex-Ez Over the Wire Balloon Dilator
Version Model Number3210
Catalog Number3210
Company DUNS076769355
Company NameHOBBS MEDICAL, INC.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com
Phone8606845875
Emailcustomerservice@hobbsmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM84932100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNQDilator, Esophageal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-12-23
Device Publish Date2016-09-21

On-Brand Devices [Flex-Ez Over the Wire Balloon Dilator]

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