AccessGUDID - DEVICE: INTRABEAM® Spherical Applicator 1.5 cm (04049539101563)

GUDID

Device Identifier (DI) Information

Brand Name: INTRABEAM® Spherical Applicator 1.5 cm
Version or Model: 304534-6000-557
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Carl Zeiss Meditec AG

Primary DI Number: 04049539101563
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342228620 *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):	No
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?
59681	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAD	System, Therapeutic, X-Ray

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121653	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

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 1.5 Centimeter

Device Record Status

Public Device Record Key: 990603e5-a390-4076-8690-7c695d8434a0
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 14, 2017