OSYFIBRE

Basic Information

• Brand Name: OSYFIBRE
• Primary DI: 03760227850150
• Version / Model: PH-EO-980-25-600-3
• Company Name: LSO MEDICAL
• Labeler DUNS: 263931746
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-12
• Public Version: 6
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: 506a3d50-d250-43c4-89f3-befd509dde26

Device Description

STERILE MEDICAL OPTICAL FIBER FOR SINGLE USE

Device Characteristics

• Single Use: Yes
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
33961	General surgical procedure kit, non-medicated, single-use	A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760227850150	GS1
Package	03760227850167	GS1	Cardboard	10	In Commercial Distribution
Package	03760227850228	GS1	Cardboard	5	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K080731	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1040	Micrometer
Lumen/Inner Diameter	600	Micrometer
Length	3	Meter

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 40 – 60 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius