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.

00850007350208 - HEMOSTATIX THERMAL SCALPEL SYSTEM2023-12-28 MODEL P8400 CONSOLE - QTY 1
00850007350222 - SHAW SCALPEL2023-12-28 FOOTSWITCH FOR P8400 CONSOLE
10850007350236 - SHAW SCALPEL2023-12-28 MODEL 8050 HANDLE - QTY 1
10850007350250 - SHAW SCALPEL2023-12-28 MODEL 9050 HANDLE - QTY 1
00850007350260 - SHAW SCALPEL2023-12-28 MODEL 5712 BLADE - QTY 10
00850007350215 - SHAW SCALPEL2023-12-28 MODEL 5710 BLADE - QTY 24
00850007350253 - SHAW SCALPEL2023-12-28 MODEL 9050 HANDLE - QTY 6
00850007350277 - SHAW SCALPEL2023-12-28 MODEL 5715 BLADE - QTY 24

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