| Primary Device ID | 00810077633014 |
| NIH Device Record Key | 4ec77516-08ed-4c21-963e-d7b33d4d792f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 272 ScopeSafe Laser Fiber |
| Version Model Number | OI-0272S-FT-000-BIG-1 |
| Catalog Number | 10211 |
| 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 |
| 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 | 00810077630013 [Primary] |
| GS1 | 00810077633014 [Package] Contains: 00810077630013 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 | 2021-04-21 |
| Device Publish Date | 2021-04-13 |
| 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 |