Laser-Lok

Basic Information

• Brand Name: Laser-Lok
• Primary DI: 00841439107409
• Version / Model: MTSBRT037
• Catalog Number: MTSBRT037
• Company Name: MEDTEC, INC.
• Labeler DUNS: 103977526
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-02
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f0dfa790-96c9-430d-b867-f75e823e73a7
• Distribution End Date: 2017-08-02

Device Description

Reusable non-sterile Laser-Lok

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
IXQ	Table, radiographic, stationary top	Radiology	892.1980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40892	Patient positioning patterned-light instrument	A fixed or variable focal distance unit used to project a light pattern, e.g., grid or crosshatch, that aids in the positioning of patients during diagnostic imaging, radiation therapy, or treatment planning procedures. It is intended to enable precise and reproducible 1, 2, or multi-dimensional alignment of a selected portion(s) of the patient's anatomy with respect to the radiation beam or beams used for diagnostic or therapeutic procedures. Light-based positioning units can be freestanding units or incorporated as a component to a diagnostic imaging or radiation therapy system. It typically includes: a light bulb, a grid to shape the pattern, and mechanical/electronic controls.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841439107409	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K973842	000

Device Sizes

Type	Value	Unit	Text
Width	2.2	Inch
Length	4.9	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Storage Environment Temperature
• Temperature Range: 52 – 85 Degrees Fahrenheit