HMR-365A

GUDID 00851272007095

Surgical Laser Fiber 365/400/580, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905 , single use, blue extension sleeves with logo, EO sterile, Dome Tip, IML label

INTERNATIONAL MEDICAL LASERS, 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: 00851272007095
• NIH Device Record Key: e43a39c3-820f-4f82-8c21-058965718f3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HMR-365A
• Version Model Number: HM-365A-DT
• Company DUNS: 078534357
• Company Name: INTERNATIONAL MEDICAL LASERS, 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: true
• 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: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 286 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851272007095 [Primary]

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: 3
• Public Version Date: 2018-06-26
• Device Publish Date: 2016-08-24

On-Brand Devices [HMR-365A]

• 00851272007163: Reusable Surgical Laser Fiber 365/400/580, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole
• 00851272007095: Surgical Laser Fiber 365/400/580, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector