LaserGuard™ Sheath
GUDID B145105370
LaserGuard Sheath, for 272 micrometer fiber, 895mm length
OPTICAL INTEGRITY INC
General/multiple surgical laser system beam guide, reusable| Primary Device ID | B145105370 |
| NIH Device Record Key | 7371fb90-dc56-4e77-802c-5e783724695b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LaserGuard™ Sheath |
| Version Model Number | 10537 |
| 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 |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
| Device Size Text, specify | 0 |
| Length | 895 Micrometer |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B145105370 [Primary] |
| HIBCC | B145105371 [Package] Package: box [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K100194
FDA Product Code
| GEX | Powered laser surgical instrument |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
[B145105370]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-07-28 |
Devices Manufactured by OPTICAL INTEGRITY INC
| 00810077630969 - SmartScope | 2024-04-01 272 MICROMETER LASER FIBER, SINGLE USE, STERILE |
| 00810077630976 - SmartScope | 2024-04-01 365 MICROMETER LASER FIBER, SINFGLE USE, STERILE |
| 00810077630983 - SmartScope | 2024-04-01 550 MICROMETER LASER FIBER, SINGLE USE, STERILE |
| 00810077630990 - SmartScope | 2024-04-01 1000 MICROMETER LASER FIBER, SINGLE USE, STERILE |
| 00810077631348 - SmartScope | 2024-04-01 200 MICROMETER LASER FIBER, SINGLE USE, DISPOSABLE |
| 00810077635711 - 200 TRUE ForTec Thulium TFL Laser Fiber | 2021-07-14 200 TRUE ForTec Thulium TFL Laser Fiber |
| 00810077635728 - 272 ForTec Thulium TFL Laser Fiber | 2021-07-14 272 ForTec Thulium TFL Laser Fiber |
| 00810077635735 - 365 ForTec Thulium TFL Laser Fiber | 2021-07-14 365 ForTec Thulium TFL Laser Fiber |
Trademark Results [LaserGuard]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LASERGUARD 97648905 not registered Live/Pending |
Berry Global, Inc. 2022-10-26 |
 LASERGUARD 79163940 4857351 Live/Registered |
NITTO EUROPE N.V. 2015-02-25 |
 LASERGUARD 78639954 not registered Dead/Abandoned |
Survcon Capital Management, Inc. 2005-05-31 |
 LASERGUARD 77485443 3796353 Live/Registered |
Crimson Trace Corporation 2008-05-28 |
 LASERGUARD 75149887 not registered Dead/Abandoned |
ARJO WIGGINS FINE PAPERS LIMITED 1996-08-14 |
 LASERGUARD 73516889 not registered Dead/Abandoned |
CLAYMAN, HENRY M. 1985-01-10 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.