DEVICE: Advanced Gynecological Applicator (08717213050051)
Device Identifier (DI) Information
Advanced Gynecological Applicator
126002-00
In Commercial Distribution
Nucletron B.V.
126002-00
In Commercial Distribution
Nucletron B.V.
Interstitial Lunar Ovoid Tube 22mm 60° Left
Device Characteristics
MR Safe | |
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? |
---|---|---|---|---|
38409 | Cervical/intrauterine brachytherapy system applicator, remote-afterloading |
A remote afterloading brachytherapy applicator specifically designed for use in cervical or intrauterine radiation therapy treatments. It is designed for temporary implantation within the body and serve as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the cervical or intrauterine anatomy. This GMDN code includes a wide variety of applicators, e.g., hollow needles, tubes, or catheters, and their associated components.
|
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 [?] |
---|---|
K161688 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
9e9db05c-c53e-4c28-9808-46b1ff41bf45
July 06, 2018
3
February 04, 2017
July 06, 2018
3
February 04, 2017
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 |
---|---|
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(770)300-9725
info.america@elekta.com
info.america@elekta.com