| Primary Device ID | B145116110 |
| NIH Device Record Key | 440d833b-1278-4050-a2bc-c44f25f2f29b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Excalibur 200 TRUE micrometer laser fiber |
| Version Model Number | SU-200-TRUE-EX |
| 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 |
| 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 |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B145116090 [Primary] |
| HIBCC | B145116110 [Package] Contains: B145116090 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 | 2020-07-21 |
| Device Publish Date | 2020-07-13 |
| 00810077631393 - 300 micron laser fiber (KTP) with ScopeGuardian sheath | 2024-10-02 300 micron laser fiber (KTP) with ScopeGuardian sheath, single use, sterile |
| 00810077631362 - 300 micron laser fiber (KTP) | 2024-09-16 300-micron laser fiber, single use disposable (KTP) |
| 00810077631355 - 300 micron laser fiber (KTP) | 2024-08-19 300 micron laser fiber, single use disposable (KTP) |
| 00810077630969 - SmartScope | 2024-04-01 272 MICROMETER LASER FIBER, SINGLE USE, STERILE |
| 00810077630976 - SmartScope | 2024-04-01 365 MICROMETER LASER FIBER, SINFGLE USE, STERILE |
| 00810077630983 - SmartScope | 2024-04-01 550 MICROMETER LASER FIBER, SINGLE USE, STERILE |
| 00810077630990 - SmartScope | 2024-04-01 1000 MICROMETER LASER FIBER, SINGLE USE, STERILE |
| 00810077631348 - SmartScope | 2024-04-01 200 MICROMETER LASER FIBER, SINGLE USE, DISPOSABLE |