AccessGUDID - DEVICE: STIC Intracompartmental Pressure Monitor (00850007350055)

GUDID

Device Identifier (DI) Information

Brand Name: STIC Intracompartmental Pressure Monitor
Version or Model: 0295-001-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: C2DX, INC.

Primary DI Number: 00850007350055
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116981210 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58297	Compartmental-pressure monitoring system, reusable	An assembly of devices designed to measure and display, periodically or continuously, the interstitial pressure in a closed fascial compartment of muscle. It typically consists of a battery-powered, hand-held, pressure-measuring instrument with a display and connected devices used to access the muscle compartment (e.g., transducing probe, extension cable). It is intended to assess chronic and/or acute compartmental syndrome, a condition of increased intra-compartmental pressures from swelling within muscle compartments and tendon sheaths due to trauma. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXC	Monitor, Pressure, Intracompartmental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K844214	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1e48940d-dbfc-48a2-a887-58c2b8cd253b
Public Version Date: May 10, 2021
Public Version Number: 2
DI Record Publish Date: April 08, 2020