| Primary Device ID | B145113511 |
| NIH Device Record Key | 987b2b5b-c28e-46aa-95cd-34e687ceb4d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ScopeSafe™Laser Fiber with ScopeGuardian™ Sheath |
| Version Model Number | 11351 |
| Company DUNS | 024050887 |
| Company Name | OPTICAL INTEGRITY INC |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 300 Micrometer |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *store at room temperature |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B145113510 [Primary] |
| HIBCC | B145113511 [Package] Contains: B145113510 Package: box [3 Units] In Commercial Distribution |
| GEX | Powered laser surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
[B145113511]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-28 |
| B145113760 | 300 micrometer ScopeSafe laser fiber with Extended 960mm Sheath and Y adapter |
| B145113740 | 272 micrometer ScopeSafe laser fiber with Extended 960mm Sheath and Y adapter |
| B145113720 | 200 micrometer ScopeSafe laser fiber with Extended 960mm Sheath and Y adapter |
| B145113680 | 272 micrometer ScopeSafe laser fiber with Sheath and Y adapter |
| B145113660 | 200 micrometer ScopeSafe laser fiber with Sheath and Y adapter |
| B145113511 | 300 micrometer ScopeSafe laser fiber with Extended 960mm Sheath |
| B145113491 | 272 micrometer ScopeSafe laser fiber with Extended 960mm Sheath |
| B145113471 | 200 micrometer ScopeSafe laser fiber with Extended 960mm Sheath |
| B145113370 | 300 micrometer ScopeSafe laser fiber with Sheath and Y adapter |
| B145111490 | 272 micrometer ScopeSafe laser fiber with ScopeGuardian Sheath, Convergent compatible |
| B145111450 | 300 micrometer ScopeSafe laser fiber with ScopeGuardian Sheath |
| B145111430 | 272 micrometer ScopeSafe laser fiber with ScopeGuardian Sheath |
| B145111410 | 200 micrometer ScopeSafe laser fiber with ScopeGuardian Sheath |