DEVICE: Ru-106 Eye Applicator with slot, type CCD 14 MBq (04049223100827)

Download: XML | JSON

Device Identifier (DI) Information

Ru-106 Eye Applicator with slot, type CCD 14 MBq
RU6.A05-S
RU6.A05-S
Eckert & Ziegler BEBIG GmbH
04049223100827
GS1
1
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
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
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KXK Source, Brachytherapy, Radionuclide
CLOSE

Sterilization

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

Storage and Handling

[?]
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.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 24, 2015

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)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+4930941084130
info@bebig.com
CLOSE