DEVICE: PROFESS (07613252727057)
Device Identifier (DI) Information
PROFESS
6001-420-000
In Commercial Distribution
6001-420-000
Stryker Leibinger GmbH & Co. KG
6001-420-000
In Commercial Distribution
6001-420-000
Stryker Leibinger GmbH & Co. KG
PROFESS(TM) REGISTRATION KIT
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47020 | Imaging lesion localization marker, external, single-use |
A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PGW | Ear, Nose, and Throat Stereotaxic Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: 5V |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Special Storage Condition, Specify: TRANSPORT:10-90%/-20-50¿C/50-106KPA |
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature: between 4 and 35 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
0429360a-febd-4329-be89-0229b357d885
March 29, 2018
2
August 24, 2016
March 29, 2018
2
August 24, 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
[?]
No Customer Contact currently defined