DEVICE: INTRABEAM® Spherical Applicator 3.5 cm (04049539101600)

Download: XML | JSON

Device Identifier (DI) Information

INTRABEAM® Spherical Applicator 3.5 cm
304534-6000-561

Carl Zeiss Meditec AG
04049539101600
GS1
1
No description.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
Intraoperative/postoperative therapeutic x-ray system spherical applicator A non-sterile component of an intraoperative/postoperative therapeutic x-ray system designed to be attached to and cover the x-ray source for direct patient contact when the system is used in the treatment of certain clinical conditions (e.g., breast cancer). It has a ball-shaped distal end that is typically inserted into a resected tumour bed for the irradiation of the tumour bed and/or margins during an operation. It may be supplied as a set of graduated sizes with a sterilization tray. This is a reusable device intended to be sterilized prior to use.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JAD System, Therapeutic, X-Ray
CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 3.5 Centimeter
CLOSE

Device Status

In Commercial Distribution
April 14, 2017

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)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE