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 |
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 |
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 | B145105370 [Primary] |
HIBCC | B145105371 [Package] Package: box [3 Units] In Commercial Distribution |
GEX | Powered laser surgical instrument |
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
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-07-28 |
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 |
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 |