AccessGUDID - DEVICE: Transfer Tube, D=3mm, L=1000mm (04065983000986)

GUDID

Device Identifier (DI) Information

Brand Name: Transfer Tube, D=3mm, L=1000mm
Version or Model: 06
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LAF1000
Company Name: BEBIG Medical GmbH

Primary DI Number: 04065983000986
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 343363100 *Terms of Use

Device Description: The Transfer Tubes and Couplings are intended for connecting HDR applicators to the treatment delivery unit (TDU).

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38300	Remote-afterloading brachytherapy system	An assembly of devices using a remotely-controlled radioactive source transport system designed to deliver a therapeutic or palliative radiation dose from a single source or source train to an anatomical region by placing the radioactive source(s) temporarily on or in the treatment site. A standard system consists of 1) a single radioactive source or source train in various forms; 2) a shielded vault to hold the sources when not used; 3) guide tubes/catheters to remotely direct the sources to the treatment site; 4) a remote-controlled mechanism to move the sources inside the guide tubes/catheters; 5) applicators; 6) computer treatment planning programs; and 7) an operator's console.	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 [?]
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: adc92dc3-fc81-4e1d-9c5f-f01a1673b05b
Public Version Date: May 06, 2024
Public Version Number: 1
DI Record Publish Date: April 26, 2024