TXMF400R

GUDID 00855950006738

Radial Fiber 400, Slim with tuohy borst

MED -FIBERS INC.

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00855950006738
• NIH Device Record Key: 79bc8cb4-0486-4dda-af79-056238838b26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TXMF400R
• Version Model Number: TXMF400R
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855950006738 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-18
• Device Publish Date: 2023-10-10

Devices Manufactured by MED -FIBERS INC.

• 00855950006721 - TXMF400RZ: 2023-10-18 Radial Fiber 400um, Slim, No luer
• 00855950006738 - TXMF400R: 2023-10-18Radial Fiber 400, Slim with tuohy borst
• 00855950006738 - TXMF400R: 2023-10-18 Radial Fiber 400, Slim with tuohy borst
• 00855950006745 - TXMF600BFS: 2023-10-18 Bare Fiber 600um 3m, luer lock, SMA Connector, sterile
• 00855950006769 - TXMFR200: 2023-10-18 Surgical Laser Fiber ILT 200PI
• 00855950006776 - TXMFR400/440: 2023-10-18 Surgical Laser Fiber 400/440um, polyamide
• 00855950006783 - MF-400-HPCS: 2023-10-18 Surgical Laser Fiber, 400/430/750, hard clad, clear tefzel, NA0.37, standard SMA905, single use, EO sterile, no extension sleeve
• 00855950006608 - MFR-300/330PI: 2023-06-02 9073/300um Surgical Laser Fiber 300/330/370PI, silica/silica, polyimide, NA 0.22, standard SMA905, reusable, extension sleeves,
• 00855950006523 - MF-Tuohy Borst Adpaters (FLO30, Male Spin/Lock, Pediatric): 2021-11-16 MF-Tuohy Borst Adpaters (MF FLO30, Male Spin/Lock, Pediatric)