DEVICE: RemB (07613154938230)
Device Identifier (DI) Information
RemB
6400009000
In Commercial Distribution
6400-009-000
STRYKER CORPORATION
6400009000
In Commercial Distribution
6400-009-000
STRYKER CORPORATION
Electric Hand Switch
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? |
---|---|---|---|---|
47864 | 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.
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Active | false |
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 |
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Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal |
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 40 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4ad7e974-bfc3-45b1-9726-c4b4f0f5b3ab
November 07, 2019
3
September 23, 2016
November 07, 2019
3
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 |
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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