AADCO

Basic Information

• Brand Name: AADCO
• Primary DI: 00840348500097
• Version / Model: LA-1200
• Catalog Number: LA-1200
• Company Name: AADCO MEDICAL, INC.
• Labeler DUNS: 153603204
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 68ab36a3-6706-4ceb-b95f-20d45f0120c3

Device Description

12" LASERX C-ARM IMAGE INTENSIFIER AIMER

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: Yes
• Has Serial Number: Yes
• 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
IWE	Monitor, Patient Position, Light-Beam	Radiology	892.5780	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36531	Aiming laser	A mains electricity (AC-powered) device assembly in which input energy is used to excite noble gas ions (e.g., helium/neon) to emit an easily visible, non-therapeutic low-level laser beam, intended to assist with aiming nonvisible therapeutic laser beam (e.g., carbon dioxide laser beam) during biostimulation and low-level therapies. Its principal emission wavelength is 633 nm (red), but it can also operate at other visible and infrared wavelengths; it may be operated in continuous and pulsed modes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840348500097	GS1