DEVICE: Swift® Applicator Tips (05060652910046)
Device Identifier (DI) Information
Swift® Applicator Tips
SWF-AT01-10
In Commercial Distribution
SWF-AT01-10
EMBLATION LIMITED
SWF-AT01-10
In Commercial Distribution
SWF-AT01-10
EMBLATION LIMITED
Box of Ten Swift® applicator tips. Swift® applicator tip is provided as a single use, non-sterile disposable tip, which is connected to the Swift® handpiece.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
Yes | |
No | |
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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? |
---|---|---|---|---|
65056 | Intraoperative gamma radiation detection system probe cover |
A polymer sheath designed to cover an intraoperative gamma radiation detection system probe (not included) to create a physical barrier between the patient and the probe. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NEY | System, Ablation, Microwave And Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K181941 | 000 |
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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No Device Sizes |
Device Record Status
3fafe807-7f97-4c05-bdf3-88f2b085ed03
August 14, 2023
2
January 17, 2019
August 14, 2023
2
January 17, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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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
[?]
No Customer Contact currently defined