| Primary Device ID | 00810077631461 |
| NIH Device Record Key | 6d6614e4-0603-4ddd-ac27-0f6233b353d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 200 micron soft tip laser fiber |
| Version Model Number | 11531 |
| Catalog Number | 11531 |
| 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 |
| Phone | 8502335512 |
| contact@opticalintegrity.com | |
| Phone | 8502335512 |
| contact@opticalintegrity.com | |
| Phone | 8502335512 |
| contact@opticalintegrity.com | |
| Phone | 8502335512 |
| contact@opticalintegrity.com | |
| Phone | 8502335512 |
| contact@opticalintegrity.com | |
| Phone | 8502335512 |
| contact@opticalintegrity.com | |
| Phone | 8502335512 |
| contact@opticalintegrity.com | |
| Phone | 8502335512 |
| contact@opticalintegrity.com | |
| Phone | 8502335512 |
| contact@opticalintegrity.com | |
| Phone | 8502335512 |
| contact@opticalintegrity.com | |
| Phone | 8502335512 |
| contact@opticalintegrity.com | |
| Phone | 8502335512 |
| contact@opticalintegrity.com | |
| Phone | 8502335512 |
| contact@opticalintegrity.com | |
| Phone | 8502335512 |
| contact@opticalintegrity.com |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810077631461 [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 | 2025-09-08 |
| Device Publish Date | 2025-08-29 |
| 00081007763051 | 200-micron Soft Tip laser fiber, single use, sterile |
| 00810077631461 | 200-micron soft tip laser fiber, single use sterile |