AccessGUDID - DEVICE: DirectLink™ (10381780515784)

GUDID

Device Identifier (DI) Information

Brand Name: DirectLink™
Version or Model: 826828
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 82-6828
Company Name: Integra LifeSciences Switzerland Sàrl

Primary DI Number: 10381780515784
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480186617 *Terms of Use

Device Description: DirectLink™ ICP Module

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	No
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?
16763	Intracranial pressure monitor	An electrically-powered device intended for intermittent or continuous measurement and display of intracranial pressure (ICP). It is used in conjunction with an invasive intracranial device (e.g., intracerebral sensor catheter) that transmits electrical signals via connected cables or pressure signals via tubing (e.g., via the air pouch method), or either telemetrically. It may include an alarm designed to alert clinical staff to an elevated ICP and may also produce a strip-chart recording or display of the ICP waveform that enables interpretation of long-term ICP trends.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWM	Device, monitoring, intracranial pressure

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152670	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
Special Storage Condition, Specify: Keep Dry
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit
Handling Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 50 Degrees Celsius
Handling Environment Temperature: between 32 and 122 Degrees Fahrenheit
Handling Environment Temperature: between 0 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c6a54138-2d8c-402f-a7b9-f4c840146ac1
Public Version Date: May 16, 2023
Public Version Number: 9
DI Record Publish Date: April 01, 2020