Universal Leveling Template, 6X10

Basic Information

• Brand Name: Universal Leveling Template, 6X10
• Primary DI: B36511269020
• Version / Model: 11-269-02
• Company Name: Aktina Corp.
• Labeler DUNS: 787178920
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6d69f3f4-a608-428c-8845-434362295467

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IXI	Block, Beam-Shaping, Radiation Therapy	Radiology	892.5710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37215	Radiation therapy beam block production plate	A dedicated device, a dish, used for the manual production of beam blocks which serve to configure a radiation field. This device is used in the production of radiotherapy blocks to cool down the melted metal, e.g., Rose's metal [consisting of lead (Pb), tin (Sn) and bismuth] when this has been poured into the moulds. It may also have the function of vibrating the metal during the cooling process to ensure equal distribution of the metal throughout the mould.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B36511269020	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K973953	000