Alma Robotic PullBack Device

Basic Information

• Brand Name: Alma Robotic PullBack Device
• Primary DI: 17290110120723
• Version / Model: 1
• Catalog Number: AAVF27011401
• Company Name: ALMA LASERS LTD.
• Labeler DUNS: 532283264
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-25
• Public Version: 5
• Public Version Date: 2020-03-05
• Public Version Status: Update
• Public Device Record Key: e3482fa2-7983-4ba5-8da9-675521ccca4f

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: 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
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63493	General/multiple surgical laser system beam guide extractor	An electrically-powered device intended to be used with a general/multiple surgical laser system during an endovenous laser therapy (EVLT) procedure, to extract (pull back, retrieve) the laser-delivery flexible fibreoptic beam guide during treatment, while the laser is activated, in a consistent, efficient and reproducible manner.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17290110120723	GS1

Premarket Submissions

Submission Number	Supplement Number
K160952	000