DEVICE: Skytron (10841736100933)
Device Identifier (DI) Information
Skytron
AIR SAFE
In Commercial Distribution
AIR SAFE
SKYTRON LLC
AIR SAFE
In Commercial Distribution
AIR SAFE
SKYTRON LLC
35 Hour filter for Skytron Smoke Evacuation System Models Smoke-E-Vac Ergon 3
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
44979 | Surgical plume evacuation system filter |
A screening device designed for use with a surgical smoke evacuation system, to entrap particulates from the plume of smoke created typically through the use of various tissue-burning surgical devices (e.g., laser, electrosurgical diathermy device), to prevent this from exhausting into the ambient air or evacuation tubing/pipeline systems. It will typically have a hydrophobic membrane that retains the particulate/bacterial pathogens through a combination of mechanical, electrostatic, or other means. The device comes in various sizes and designs. This is a reusable device, typically with a limited lifetime (e.g., 5 hours, 20 procedures, or weekly exchange).
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FYD | APPARATUS, EXHAUST, SURGICAL |
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 9.5 Millimeter |
Outer Diameter: 0.25 Inch |
Outer Diameter: 0.875 Inch |
Outer Diameter: 22 Millimeter |
Outer Diameter: 6.4 Millimeter |
Outer Diameter: 0.375 Inch |
Device Record Status
89bcfa30-59a5-4cb0-bba4-40ebc075686f
March 29, 2018
2
September 19, 2016
March 29, 2018
2
September 19, 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 |
---|---|---|---|---|---|
30841736100937 | 2 | 10841736100933 | In Commercial Distribution | Box |
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)759-8766
info@skytron.us
info@skytron.us