DEVICE: CORE (07613154121021)
Device Identifier (DI) Information
CORE
5400111000S1
In Commercial Distribution
5400111000S1
STRYKER CORPORATION
5400111000S1
In Commercial Distribution
5400111000S1
STRYKER CORPORATION
UHT Handswitch with Reversed Safety Switch
Device Characteristics
Labeling does not contain MRI Safety Information | |
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 |
---|---|
Surgical power tool hand-switch | A handle-like device that is attached (clips or is slid onto the cylindrical barrel) to an electrically- or pneumatically-powered surgical power tool handpiece or motor of the micro types (a drill or a saw) so that the two devices interact to function as a switch used by the operating surgeon to hand activate (start and stop) the handpiece/motor. It is typically made of metal and/or synthetic materials and will typically include a sliding lock that, when brought into use by the surgeon, will lock the handle in the "On" position. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE |
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 -20 and 40 Degrees Celsius |
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
b8f18e8a-beb1-45c8-b54d-93eec2465316
March 29, 2018
2
September 23, 2016
March 29, 2018
2
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