| Primary Device ID | B145110721 |
| NIH Device Record Key | 6e42dab0-462a-473b-ac32-33631b4e80ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Calculase Laser Fiber |
| Version Model Number | 11070 |
| 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 |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| Device Size Text, specify | 0 |
| Outer Diameter | 272 Micrometer |
| 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 | B145110700 [Primary] |
| HIBCC | B145110721 [Package] Contains: B145110700 Package: box [3 Units] In Commercial Distribution |
| GEX | Powered laser surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
[B145110721]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-03 |
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| B14527750300U1C31 | 300 micrometer Calculase Laser Fiber |
| B14527750272U1C31 | 272 micrometer Calculase Laser Fiber |
| B14527750200U1C31 | 200 micrometer Calculase Laser Fiber |
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| B145110801 | 365 micrometer Calculase Laser Fiber |
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