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 ID: 00850007350055
• NIH Device Record Key: 1e48940d-dbfc-48a2-a887-58c2b8cd253b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STIC Intracompartmental Pressure Monitor
• Version Model Number: 0295-001-000
• Company DUNS: 116981210
• Company Name: C2DX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com
• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com
• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com
• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com
• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com
• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com
• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com
• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com
• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com
• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com
• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com
• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com
• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com
• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com
• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com
• Phone: (888) 902-2239
• Email: c2dx@c2dxinc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850007350055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K844214

FDA Product Code

• LXC: Monitor, Pressure, Intracompartmental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-16
• Device Publish Date: 2020-04-08

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• 10850007350236 - SHAW SCALPEL: 2023-12-28 MODEL 8050 HANDLE - QTY 1
• 10850007350250 - SHAW SCALPEL: 2023-12-28 MODEL 9050 HANDLE - QTY 1
• 00850007350260 - SHAW SCALPEL: 2023-12-28 MODEL 5712 BLADE - QTY 10
• 00850007350215 - SHAW SCALPEL: 2023-12-28 MODEL 5710 BLADE - QTY 24
• 00850007350253 - SHAW SCALPEL: 2023-12-28 MODEL 9050 HANDLE - QTY 6
• 00850007350277 - SHAW SCALPEL: 2023-12-28 MODEL 5715 BLADE - QTY 24