| Primary Device ID | B145105480 |
| NIH Device Record Key | 4c6da94b-2cf6-4160-9a5c-320bfc8397b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Optical Integrity Laser Fiber |
| Version Model Number | 10548 |
| 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 |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 365 Micrometer |
| 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 |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B145105480 [Primary] |
| HIBCC | B145105481 [Package] Package: box [3 Units] In Commercial Distribution |
| GEX | Powered laser surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
Ethylene Oxide
[B145105480]
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 |