DEVICE: Surface Applicator Set (00858012005595)
Device Identifier (DI) Information
Surface Applicator Set
710339
In Commercial Distribution
SK1000
Icad, Inc.
710339
In Commercial Distribution
SK1000
Icad, Inc.
Surface Applicator Set
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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59683 | Intraoperative/postoperative therapeutic x-ray system surface applicator |
A non-sterile component of an intraoperative/postoperative therapeutic x-ray system designed to be attached to and cover the x-ray source for direct patient contact when the system is used for the treatment of certain clinical conditions (e.g., skin tumours). It has a flat distal end that is typically used to irradiate a body surface treatment site, e.g., skin that does not need surgical exposure. It is typically supplied in a range of sizes (diameters). This is a reusable device intended to be sterilized prior to use.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JAD | System, Therapeutic, X-Ray |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K083734 | 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
ed2ae4b8-5254-474f-a983-5cad3db88388
July 06, 2018
3
September 20, 2016
July 06, 2018
3
September 20, 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 |
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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