| Primary Device ID | B145115310 |
| NIH Device Record Key | a8e63f79-911b-454f-8f4f-ecb997b26c7a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ScopeSafe laser fiber with Soft Tip Stand Off Jack |
| Version Model Number | 11531 |
| Company DUNS | 024050887 |
| Company Name | OPTICAL INTEGRITY INC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 |
| 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 |
| 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 | B145115310 [Primary] |
| 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 | 2018-07-16 |
| Device Publish Date | 2018-06-15 |
| 00810077631461 - 200 micron soft tip laser fiber | 2025-09-08 200-micron soft tip laser fiber, single use sterile |
| 00081007763051 - 200 micron Soft Tip laser fiber | 2025-05-28 200-micron Soft Tip laser fiber, single use, sterile |
| 00810077631454 - 357 micron laser fiber | 2025-05-08 357-micron laser fiber, single use, sterile |
| 00810077631447 - Stripper Scribe Tool | 2025-04-21 |
| 00810077631430 - 200 micron Excalibur DC laser fiber | 2025-03-10 200-micron Excalibur DC Laser fiber |
| 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) |