AccessGUDID - DEVICE: Transfer Tube,D=3mm,L=1000mm,QuickFix (SagiNova) (04049223103675)

GUDID

Device Identifier (DI) Information

Brand Name: Transfer Tube,D=3mm,L=1000mm,QuickFix (SagiNova)
Version or Model: LAF1000#05
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LAF1000
Company Name: Eckert & Ziegler BEBIG GmbH

Primary DI Number: 04049223103675
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2024
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38437	Brachytherapy system remote afterloading source transfer tube	A tube or hose-like catheter with connectors at both ends used to interface the brachytherapy applicator to the remote afterloading system. The transfer tube, when attached to the applicator and the afterloading system, provides a continuous closed passage that allows for moving either a radioactive source(s) and/or positioning markers from the shielded source storage compartment of the remote afterloading brachytherapy system into appropriate positions within a brachytherapy applicator that has been positioned at a location either on the surface of, or within, the patient.	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 [?]
Premarket Submission Number Not Available/Not Released

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: 826e6a21-d576-4433-b756-d2011a12b069
Public Version Date: February 29, 2024
Public Version Number: 4
DI Record Publish Date: October 05, 2016