NA

Basic Information

• Brand Name: NA
• Primary DI: EOBN220051S0
• Version / Model: General Surgery Fiber 400um
• Company Name: OBERON GmbH Fiber Technologies
• Labeler DUNS: 312889060
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-18
• Public Version: 7
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: fc31c1c4-0689-4012-965e-4cfd1aa932e5

Device Description

Laser Surgery Fiber, core 400µm, clad 420µm, fiber OD 950µm, white Vestodur Jacket with length marking, standard SMA 905 connector with knurl nut, PEEK protection cap, engraved extension sleeve red, black bend protection, distal flat tip, cleaved, NA 0.22, length 3m +/-0,2m, sterile EO, double packed

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

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
61474	General/multiple surgical laser system beam guide, reusable	A surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EOBN220051S0	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K140470	000