AccessGUDID - DEVICE: INTRABEAM® Surface Applicator Set 3.0 cm (04049539101464)

GUDID

Device Identifier (DI) Information

Brand Name: INTRABEAM® Surface Applicator Set 3.0 cm
Version or Model: 304534-3001-532
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Carl Zeiss Meditec AG

Primary DI Number: 04049539101464
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?
59683	Intraoperative/postoperative therapeutic x-ray system surface 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 for the treatment of certain clinical conditions (e.g., skin tumours). It has a flat distal end that is typically used to irradiate a body surface treatment site, e.g., skin that does not need surgical exposure. It is typically supplied in a range of sizes (diameters). 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 [?]
K130549	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: 3.0 Centimeter

Device Record Status

Public Device Record Key: 9a3cc4b2-e327-46ee-aa68-7960b7cee64c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 14, 2017