Flex-Ez Stylet Wire Balloon Dilator 3758

GUDID M84937580

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 IDM84937580
NIH Device Record Key0a47b435-3228-4588-93cb-0bbbd3ac3611
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlex-Ez Stylet Wire Balloon Dilator
Version Model Number3758
Catalog Number3758
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM84937580 [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 Stylet Wire Balloon Dilator]

M84937620A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937600A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937580A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937560A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937540A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937520A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937440A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937420A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937400A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937380A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937360A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937340A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937320A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937160A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937140A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937120A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937100A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically
M84937080A long, thin, flexible tube with an inflatable balloon at its distal tip used to endoscopically

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