DEVICE: DIRECTLINK (10886704075646)
Device Identifier (DI) Information
DIRECTLINK
82-6840
In Commercial Distribution
826840
Medos International Sàrl
82-6840
In Commercial Distribution
826840
Medos International Sàrl
DirectLink ICP Extension Cable
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Electrical-only medical device connection cable, reusable | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GWM | DEVICE, MONITORING, INTRACRANIAL PRESSURE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit |
Handling Environment Humidity: between 15 and 85 Percent (%) Relative Humidity |
Handling Environment Temperature: between 32 and 122 Degrees Fahrenheit |
Handling Environment Temperature: between 0 and 50 Degrees Celsius |
Special Storage Condition, Specify: Waste Electrical and Electronic Equipment |
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity |
Storage Environment Temperature: between 0 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
c0e9f568-8471-4e01-a7f7-57367ecbe4ee
March 29, 2018
2
March 22, 2016
March 29, 2018
2
March 22, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)255-2500
xx@xx.xx
xx@xx.xx