Primary Device ID | B145104430 |
NIH Device Record Key | ebf507ac-1bb7-4c01-b6d1-f1f1105a938b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Optical Integrity Laser Fiber |
Version Model Number | 10443 |
Company DUNS | 024050887 |
Company Name | OPTICAL INTEGRITY 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 | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 600 Micrometer |
Device Size Text, specify | 0 |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B145104430 [Primary] |
HIBCC | B145104431 [Package] Package: box [3 Units] In Commercial Distribution |
GEX | Powered laser surgical instrument |
Steralize Prior To Use | true |
Device Is Sterile | true |
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
[B145104430]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-07-28 |
B145P00121000R0 | 1000 micrometer laser fiber reusable |
B145P001210000 | 1000 micrometer laser fiber |
B145P00120550R0 | 550 micrometer laser fiber reusable |
B145P001205500 | 550 micrometer laser fiber |
B145P00120365R0 | 365 micrometer laser fiber reusable |
B145P001203650 | 365 micrometer laser fiber |
B145114961 | 550 micrometer laser fiber with extension sleeve, reusable, nonsterile |
B145114141 | 550 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve |
B145114121 | 365 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve |
B145114101 | 272 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve |
B145112131 | 1000 micrometer laser fiber with SMA extension sleeve |
B145109260 | 550 micrometer laser fiber, 4m length |
B145108450 | 1000 micrometer laser fiber, Trimedyne compatible |
B145108440 | 550 micrometer laser fiber, Trimedyne compatible |
B145108430 | 365 micrometer laser fiber, Trimedyne compatible |
B145107410 | 550 micrometer laser fiber with extension sleeve, reusable |
B145107390 | 365 micrometer laser fiber with extension sleeve, reusable |
B145106780 | 600 micrometer reduced buffer with SMA 905 Connector, reusable |
B145106740 | 365 micrometer Laser fiber, 4m length |
B145106620 | 400 micrometer Laser fiber |
B145106280 | 550 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve |
B145106270 | 365 micrometer laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve |
B145105920 | 550 micrometer laser fiber with extension sleeve |
B145105480 | 365 micrometer laser fiber with extension sleeve |
B145104870 | 600 micrometer laser fiber without boot |
B145104430 | 600 micrometer laser fiber with SMA 905 Connector |
B145103910 | 1000 micrometer laser fiber reusable |
B145103900 | 550 micrometer laser fiber reusable |
B145103890 | 365 micrometer laser fiber reusable |
B145102390 | 1000 micrometer laser fiber |
B145102380 | 550 micrometer laser fiber |
B145102370 | 365 micrometer laser fiber |
B145101530 | 600 micrometer laser fiber without sleeve |
B145101510 | 600 micrometer laser fiber without sleeve reusable |