DEVICE: Ovoid pair, ø 25 mm (10810563022978)
Device Identifier (DI) Information
Ovoid pair, ø 25 mm
GM11013620
In Commercial Distribution
GM11013620
VARIAN MEDICAL SYSTEMS, INC.
GM11013620
In Commercial Distribution
GM11013620
VARIAN MEDICAL SYSTEMS, INC.
No description.
Device Characteristics
MR Conditional | |
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? |
---|---|---|---|---|
38407 | Vaginal brachytherapy system applicator, remote-afterloading |
A remote afterloading brachytherapy applicator specifically designed for use in vaginal or transvaginal radiation therapy treatments. It is designed for temporary implantation within the body and serves as a guide for computer-controlled placement and removal of single or multiple radioactive sources in the vaginal area. This GMDN code includes a variety of applicators, e.g., hollow needles or tubes and 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 [?] |
---|---|
K243939 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
18e0b0cc-de9a-4022-9ab1-c6610ce30e0d
May 30, 2025
1
May 22, 2025
May 30, 2025
1
May 22, 2025
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:
00810563022971
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined