DEVICE: Breast Template, triple plane, 8mm (Paris) without Button (04049223118624)

Device Identifier (DI) Information

Breast Template, triple plane, 8mm (Paris) without Button
LLZ21-08
In Commercial Distribution
LLZ21-08
Eckert & Ziegler BEBIG GmbH
04049223118624
GS1

1
331080432 *Terms of Use
No description.
CLOSE

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
General-purpose brachytherapy system applicator, remote-afterloading A general-purpose remote afterloading brachytherapy applicator intended to be used to facilitate the delivery of radiation therapy treatments that are not specifically designed for use in a particular anatomical region. It is designed for temporary introduction into the body and functions as a guide for computer-controlled placement and removal of single or multiple radioactive sources in a treatment area. This device includes a variety of applicators (e.g., hollow needle, tube, catheter), and their associated components [e.g., introducer sheath, guidewire].
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JAQ System, Applicator, Radionuclide, Remote-Controlled
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K142986 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

ca5f0f29-8bad-4bcc-98b4-4d08b0c3586c
July 06, 2018
4
October 06, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+4930941084130
info@bebig.com
CLOSE