HMR-272A

GUDID 00851272007156

Reusable Surgical Laser Fiber 272/300/450, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® 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 ID00851272007156
NIH Device Record Keya8f91ab3-4f13-40e7-ba57-d7eb86dbbc74
Commercial Distribution StatusIn Commercial Distribution
Brand NameHMR-272A
Version Model NumberHMR-272A
Company DUNS078534357
Company NameINTERNATIONAL MEDICAL LASERS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 286 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100851272007156 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


[00851272007156]

Radiation Sterilization;Moist Heat or Steam Sterilization;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-06-26
Device Publish Date2016-08-24

Devices Manufactured by INTERNATIONAL MEDICAL LASERS, INC.

00851272007002 - HM-10002018-06-26 Surgical Laser Fiber 1000/1100/1450, hard clad, blue tefzel, NA 0.22, damage resistant SMA905, single use, blue extension sleeve
00851272007019 - HM-200A-BT2018-06-26 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-DT2018-06-26 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-DT2018-06-26 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-BT2018-06-26 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-FB2018-06-26 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-FB2018-06-26 Surgical Laser Fiber 272/300/450 4m fiber, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905 , single use,
00851272007071 - HM-365A2018-06-26 Surgical Laser Fiber 365/400/580, hard clad, blue tefzel, NA 0.22, Absorbing Dark Hole Connector® SMA905 , single use, blue ext

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