| Primary Device ID | 00810077630099 |
| NIH Device Record Key | cfe657b4-39eb-4be4-b602-9cd3d516b858 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 272 ScopeSafe Laser Fiber |
| Version Model Number | KS-272S-FT-000-BLU-1 |
| Catalog Number | 10367 |
| Company DUNS | 024050887 |
| Company Name | OPTICAL INTEGRITY INC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| 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 | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 Micrometer |
| Outer Diameter | 272 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 |
|---|---|
| GS1 | 00810077630099 [Primary] |
| GS1 | 00810077633090 [Package] Package: Carton [3 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 | 2021-05-19 |
| Device Publish Date | 2021-05-11 |
| 00810077633014 | 272 ScopeSafe Laser Fiber, Single Use |
| 00810077630099 | 272 ScopeSafe Laser Fiber |
| 00810077630075 | 272 ScopeSafe Laser Fiber, Reusable |
| 00810077630174 | 272 ScopeSafe Laser Fiber |
| 00810077635520 | 272 ScopeSafe Laser Fiber |