Flex-Ez Guidewire 3410

GUDID M84934100

A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interventional device (e.g., a stent or dilator) within an endoscope lumen into the gastrointestinal (GI) tract or the tracheobronchial tree. This is a single-use device

HOBBS MEDICAL, INC.

Gastro-urological guidewire, single-use
Primary Device IDM84934100
NIH Device Record Keyc8bd7913-bf33-4b09-976a-b56b5c05c0c0
Commercial Distribution Discontinuation2025-12-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameFlex-Ez Guidewire
Version Model Number3410
Catalog Number3410
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM84934100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EYBCatheter, Ureteral, Gastro-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-12-22
Device Publish Date2016-09-21

On-Brand Devices [Flex-Ez Guidewire]

M84934120A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interven
M84934100A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interven
M84934060A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interven

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