STIC Intracompartmental Pressure Monitor

GUDID 00850007350055

The STIC Intracompartmental Pressure Monitor system is intended to measure compartmental pressure to aid in diagnosis of compartment syndrome.

C2DX, INC.

Compartmental-pressure monitoring system, reusable
Primary Device ID00850007350055
NIH Device Record Key1e48940d-dbfc-48a2-a887-58c2b8cd253b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTIC Intracompartmental Pressure Monitor
Version Model Number0295-001-000
Company DUNS116981210
Company NameC2DX, 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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(888) 902-2239
Emailc2dx@c2dxinc.com
Phone(888) 902-2239
Emailc2dx@c2dxinc.com
Phone(888) 902-2239
Emailc2dx@c2dxinc.com
Phone(888) 902-2239
Emailc2dx@c2dxinc.com
Phone(888) 902-2239
Emailc2dx@c2dxinc.com
Phone(888) 902-2239
Emailc2dx@c2dxinc.com
Phone(888) 902-2239
Emailc2dx@c2dxinc.com
Phone(888) 902-2239
Emailc2dx@c2dxinc.com
Phone(888) 902-2239
Emailc2dx@c2dxinc.com
Phone(888) 902-2239
Emailc2dx@c2dxinc.com
Phone(888) 902-2239
Emailc2dx@c2dxinc.com
Phone(888) 902-2239
Emailc2dx@c2dxinc.com
Phone(888) 902-2239
Emailc2dx@c2dxinc.com
Phone(888) 902-2239
Emailc2dx@c2dxinc.com
Phone(888) 902-2239
Emailc2dx@c2dxinc.com
Phone(888) 902-2239
Emailc2dx@c2dxinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850007350055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXCMonitor, Pressure, Intracompartmental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-16
Device Publish Date2020-04-08

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.