DEVICE: CORE, Maestro (07613154511501)
Device Identifier (DI) Information
CORE, Maestro
5400207000S1
In Commercial Distribution
5400-207-000S1
STRYKER CORPORATION
5400207000S1
In Commercial Distribution
5400-207-000S1
STRYKER CORPORATION
Large Non-exhausting Footpedal
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
58029 | Foot-switch, pneumatic |
A gas-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g. a pneumatic surgical saw, pneumatic wire driver, pneumatic surgical power tool system control unit) to which it is connected typically via one or more hoses and which is dependent upon pressurized gas [e.g., medical air, nitrogen (N2)]. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HBB | MOTOR, DRILL, PNEUMATIC |
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 Humidity: between 10 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
93db6569-65ff-4c22-b2d6-f5a4f8faac60
July 05, 2019
4
September 23, 2016
July 05, 2019
4
September 23, 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)253-3210
Inst.Stryker.cs@Stryker.com
Inst.Stryker.cs@Stryker.com