Laser Surgery Fibers and Probes LL11058s

GUDID 04260155591846

Otology probe long 300µm

A.R.C. Laser GmbH

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 04260155591846
• NIH Device Record Key: e7fbfd02-d63d-4924-a638-97ca2e92155f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Laser Surgery Fibers and Probes
• Version Model Number: LL11058s
• Catalog Number: LL11058s
• Company DUNS: 314885641
• Company Name: A.R.C. Laser GmbH
• 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	04260155591433 [Primary]
GS1	04260155591631 [Package]; Contains: 04260155591433; Package: [15 Units]; In Commercial Distribution
GS1	04260155591846 [Package]; Contains: 04260155591433; Package: [30 Units]; In Commercial Distribution
GS1	04260155592898 [Package]; Contains: 04260155591433; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161403

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

[04260155591846]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-28

On-Brand Devices [Laser Surgery Fibers and Probes]

• 04260155591921: Otology probe curved tip 20° universal centering
• 04260155591914: Otology probe long universal centering
• 04260155591907: Bare fiber 400 μm universal centering 1470 nm
• 04260155591891: Bare fiber 600 μm/400 µm
• 04260155591884: Bare fiber 400μm/300µm
• 04260155591877: Endo probe 25 gauge
• 04260155591655: Endo probe 20 gauge
• 04260155591853: Otology probe short 300µm
• 04260155591846: Otology probe long 300µm
• 04260155591426: Flexible endo probe 23 gauge
• 04260155591730: Bare Fiber 400µm
• 04260155591938: Endoprobe 30° 23 gauge
• 4260155591822: Endoprobe 30° 25 gauge
• 4260155591815: Bare Fiber 600µm
• 4260155591808: Bare Fiber 200µm
• 04260155591792: Bare Fiber 300µm
• 04260155591785: Bare Fiber 600µm universal centering
• 04260155591778: Bare Fiber 300µm
• 04260155591761: Endoprobe 21 gauge
• 04260155590443: Endoprobe straight 20 gauge
• 04260155591747: Endo Probe 23 Gauge
• 04260155592256: HiFlex Fiber, 300 micrometer, Universal Centering
• 04260155592126: HiFlex Fiber, 300 micrometer
• 04260155591983: HiFlex Fiber, 400 micrometer, Universal Centering
• 04260155592287: HiFlex Fiber, 400 micrometer
• 04260155592348: HiFlex Fiber, 600 micrometers, Universal Centering