DEVICE: Advanced Gynecological Applicator (08717213050266)

Device Identifier (DI) Information

Advanced Gynecological Applicator
126010-00
In Commercial Distribution

Nucletron B.V.
08717213050266
GS1

1
415269930 *Terms of Use
Vaginal Cap 26mm Left
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Device Characteristics

MR Safe
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

[?]
Product Code Product Code Name
JAQ System, applicator, radionuclide, remote-controlled
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K161688 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

237b373a-1196-4054-a541-61da5476440c
July 06, 2018
3
February 04, 2017
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
Yes
08717213050273
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(770)300-9725
info.america@elekta.com
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