AccessGUDID - DEVICE: X-Ray Marker 28, L=325mm (04049223106669)

GUDID

Device Identifier (DI) Information

Brand Name: X-Ray Marker 28, L=325mm
Version or Model: LAH02-28#03
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LAH02-28
Company Name: Eckert & Ziegler BEBIG GmbH

Primary DI Number: 04049223106669
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 331080432 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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].

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].

FDA Product Code

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Product Code	Product Code Name
JAQ	System, Applicator, Radionuclide, Remote-Controlled

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142986	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e94a6cb8-dca4-4fdc-a2e7-109728bde54e
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: October 06, 2016