AccessGUDID - DEVICE: Ru-106 Eye Applicator, type CCB 19 MBq (04049223100834)

GUDID

Device Identifier (DI) Information

Brand Name: Ru-106 Eye Applicator, type CCB 19 MBq
Version or Model: RU6.A06
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RU6.A06
Company Name: Eckert & Ziegler BEBIG GmbH

Primary DI Number: 04049223100834
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?	Labeling does not contain MRI Safety Information
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
Manual brachytherapy source, temporary placement	A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope in a form that is intended for temporary placement in the body and removal after a specified treatment time. It is used in brachytherapy applications that require direct manual or endoscopically-guided placement and removal. Manually inserted sources intended for temporary placement come in a variety of forms, e.g., encapsulated, sealed, plated, foil or embedded sources. It can be inserted directly into the patient or be implanted using catheters or applicators and may take the form of needles, spheres, ovoids, seeds, wires or liquids included in the cuffed portion of a catheter.

GMDN Preferred Term Name

GMDN Definition

Manual brachytherapy source, temporary placement

A device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope in a form that is intended for temporary placement in the body and removal after a specified treatment time. It is used in brachytherapy applications that require direct manual or endoscopically-guided placement and removal. Manually inserted sources intended for temporary placement come in a variety of forms, e.g., encapsulated, sealed, plated, foil or embedded sources. It can be inserted directly into the patient or be implanted using catheters or applicators and may take the form of needles, spheres, ovoids, seeds, wires or liquids included in the cuffed portion of a catheter.

FDA Product Code

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Product Code	Product Code Name
KXK	Source, Brachytherapy, Radionuclide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K931393	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Applicators must be stored in a dry state and with sufficient shielding in a locked safe. The Ru-106 eye applicator must not be stored in liquids or in the vicinity of media that promote corrosion.

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6410934e-1079-417e-b3eb-93b7af25d2d1
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015