HMR-1000

GUDID 00851272007132

Reusable Surgical Laser Fiber 1000/1100/1450, hard clad, blue tefzel, NA 0.22, damage resistant SMA905, reusable, blue extension sleeves with logo, EO sterile, Flat Tip, IML label

INTERNATIONAL MEDICAL LASERS, INC.

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: 00851272007132
• NIH Device Record Key: 56efe39e-af0d-425e-b4bb-6fb65fae328e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HMR-1000
• Version Model Number: HMR-1000
• 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: false
• 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	00851272007132 [Primary]

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

[00851272007132]

Radiation Sterilization;Ethylene Oxide;Moist Heat or Steam Sterilization

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

Devices Manufactured by INTERNATIONAL MEDICAL LASERS, INC.

• 00851272007002 - HM-1000: 2018-06-26 Surgical Laser Fiber 1000/1100/1450, hard clad, blue tefzel, NA 0.22, damage resistant SMA905, single use, blue extension sleeve
• 00851272007019 - HM-200A-BT: 2018-06-26 Surgical Laser Fiber 200/240/400, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905 , single use, blue ext
• 00851272007026 - HM-200A-DT: 2018-06-26 Surgical Laser Fiber 200/240/400, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905 , single use, blue ext
• 00851272007033 - HM-272A-DT: 2018-06-26 Surgical Laser Fiber 272/300/450, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905 , single use, blue ext
• 00851272007040 - HM-272A-BT: 2018-06-26 Surgical Laser Fiber 272/300/450, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905 , single use, blue ext
• 00851272007057 - HM-272A-L-DT-FB: 2018-06-26 Surgical Laser Fiber 272/300/450 4m fiber, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905 , single use,
• 00851272007064 - HM-272A-L-FB: 2018-06-26 Surgical Laser Fiber 272/300/450 4m fiber, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905 , single use,
• 00851272007071 - HM-365A: 2018-06-26 Surgical Laser Fiber 365/400/580, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905 , single use, blue ext