Side Ported Needle - 20G

GUDID 00850007350185

Side Ported Needle - 20G

C2DX, INC.

Compartmental-pressure monitoring system, single-use
Primary Device ID00850007350185
NIH Device Record Key37023cab-ee38-4092-8305-beb5267c5290
Commercial Distribution StatusIn Commercial Distribution
Brand NameSide Ported Needle - 20G
Version Model Number0295-007-000
Company DUNS116981210
Company NameC2DX, INC.
Device Count6
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

Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com
Phone888-902-2239
Emailc2dx@c2dxinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850007350185 [Unit of Use]
GS110850007350182 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXCMonitor, Pressure, Intracompartmental

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-11
Device Publish Date2022-05-03

Devices Manufactured by C2DX, INC.

00850007350321 - Wire Guide2026-02-18
00850007350338 - Salivary Access Dilator Set2026-02-18
00850007350345 - Kolenda Salivary Introducer Set - 5.02026-02-18
00850007350352 - Kolenda Salivary Introducer Set - 6.02026-02-18
00850007350369 - NGage Salivary Stone Extractor2026-02-18
00850007350376 - NCircle Tipless Salivary Stone Extractor2026-02-18
00850007350383 - Sialocath Salivary Duct Catheter2026-02-18
00850007350390 - Advance Salivary Duct Balloon Catheter Set - 1.52026-02-18

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