MF-400-HPCS

GUDID 00855950006332

Surgical Laser Fiber, 400/430/750, hard clad, clear tefzel, NA0.37, standard SMA905, single use, EO sterile, extension sleeve, Flat Tip, MF label

MED -FIBERS INC.

General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00855950006332
• NIH Device Record Key: 012a93ef-96d2-4a34-a1ae-1b4b96013b04
• Commercial Distribution Discontinuation: 2018-01-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MF-400-HPCS
• Version Model Number: MF-400-HPCS
• Company DUNS: 058701385
• Company Name: MED -FIBERS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855950006332 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K124003

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-17

On-Brand Devices [MF-400-HPCS]

• 00855950006332: Surgical Laser Fiber, 400/430/750, hard clad, clear tefzel, NA0.37, standard SMA905, single use,
• 00855950006783: Surgical Laser Fiber, 400/430/750, hard clad, clear tefzel, NA0.37, standard SMA905, single use,