Accu-Beam

Basic Information

• Brand Name: Accu-Beam
• Primary DI: B1777021580
• Version / Model: 7021-58
• Company Name: TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
• Labeler DUNS: 130213366
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-09
• Public Version: 1
• Public Version Date: 2024-01-17
• Public Version Status: New
• Public Device Record Key: a21d82b1-8be4-41cd-8faf-f5395562b358

Device Description

Zeiss/CJ Pico Adaptor

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: No
• 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
HHR	Laser, Surgical, Gynecologic	Obstetrics/Gynecology	884.4550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36184	Laser adaptor	A connecting device, usually a small part, designed to join a device or component to a laser, or join devices being used with the laser, or to make any of these devices compatible so that they mate together (e.g., a laser contact probe from one manufacturer connect to the laser delivery arm of a laser from a different manufacturer). Included are optical couplers designed to connect a laser source to a fibreoptic laser delivery system. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B1777021580	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K864378	000