| Primary Device ID | B145116711 |
| NIH Device Record Key | fdea7bf0-01da-40ff-b326-a51251457d4f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartScope laser fiber |
| Version Model Number | 11547 |
| Company DUNS | 024050887 |
| Company Name | OPTICAL INTEGRITY INC |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Outer Diameter | 200 Micrometer |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B145115470 [Primary] |
| HIBCC | B145116711 [Package] Contains: B145115470 Package: carton [5 Units] In Commercial Distribution |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-31 |
| Device Publish Date | 2018-11-28 |
| B145116791 | 1000 micrometer SmartScope laser fiber, signel use, sterile, round tip |
| B145116771 | 550 micrometer SmartScope laser fiber, single use, sterile, round tip |
| B145116751 | 365 micrometer SmartScope laser fiber, single use, sterile, round tip |
| B145116731 | 272 micrometer SmartScope laser fiber single use, sterile, round tip |
| B145116711 | 200 micrometer SmartScope laser fiber, single use, sterile, round tip |