Faller Stylet FS-404

GUDID 00792079001827

Medionics International Inc

Subcutaneous tunneller, single-use
Primary Device ID00792079001827
NIH Device Record Keyb1a15c68-4f28-4664-8089-b1a9c242047e
Commercial Distribution StatusIn Commercial Distribution
Brand NameFaller Stylet
Version Model NumberFS-404
Catalog NumberFS-404
Company DUNS241421320
Company NameMedionics International 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone905-472-6544
Emailinfo@medionics.com
Phone905-472-6544
Emailinfo@medionics.com
Phone905-472-6544
Emailinfo@medionics.com
Phone905-472-6544
Emailinfo@medionics.com
Phone905-472-6544
Emailinfo@medionics.com
Phone905-472-6544
Emailinfo@medionics.com
Phone905-472-6544
Emailinfo@medionics.com
Phone905-472-6544
Emailinfo@medionics.com
Phone905-472-6544
Emailinfo@medionics.com
Phone905-472-6544
Emailinfo@medionics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100792079001827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FJSCatheter, Peritoneal, Long-Term Indwelling

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-10
Device Publish Date2026-02-02

On-Brand Devices [Faller Stylet]

00792079001223FS-403
00792079001216FS-402
00792079000424FS-401
00792079001827FS-404

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.