DEVICE: Cervical Applicator Set (00858012005557)
Device Identifier (DI) Information
Cervical Applicator Set
710746
In Commercial Distribution
CG1000
Icad, Inc.
710746
In Commercial Distribution
CG1000
Icad, Inc.
Cervical Applicator Set
Device Characteristics
MR Safe | |
No | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
38408 | Cervical/intrauterine brachytherapy system applicator, manual |
A manual brachytherapy applicator specifically designed to be used in cervical and/or intrauterine radiation therapy treatments. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided placement or diagnostic imaging system guided placement, of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes cervical/intrauterine applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JAQ | System, Applicator, Radionuclide, Remote-Controlled |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K123442 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ffd698a7-71cb-43ee-8401-33eb3f05ccc3
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