AccessGUDID - DEVICE: Beam Block Tray, Lexan, Digital MLC Coding, Star Pattern (B36556000HL0)

GUDID

Device Identifier (DI) Information

Brand Name: Beam Block Tray, Lexan, Digital MLC Coding, Star Pattern
Version or Model: 56-000-HL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aktina Corp.

Primary DI Number: B36556000HL0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 787178920 *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?
42262	Manual-aperture-control therapeutic x-ray system collimator, non-motorized	A non-motorized, x-ray beam-limiting and shaping device that is a component of a therapeutic x-ray system and that is adjusted manually. It is attached to the x-ray tube housing assembly and adjusts the size and shape of the x-ray beam to match the size and shape of a predefined target area or the shape of a x-ray cassette used for quality assurance purposes. It is used in radiation therapy applications to limit the effects of scattered radiation and to provide patient protection by limiting or eliminating exposure to non-target body areas during treatment. This device is specifically designed for use with an x-ray simulation or therapeutic x-ray system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K964840	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 01fa3a86-6b9c-4225-84db-f71b56dd293b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016