Primary Device ID | B145113350 |
NIH Device Record Key | 7d077b09-276e-4fa0-933d-891cfbebe4ac |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Q-Lase™ Side-Fire Fiber with Rotating Tip |
Version Model Number | 11335 |
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 | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 800 Micrometer |
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 |
Storage Environment Temperature | Between 10 Degrees Celsius and 37 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B145113350 [Primary] |
HIBCC | B145113351 [Package] Package: box [3 Units] In Commercial Distribution |
GEX | Powered laser surgical instrument |
Steralize Prior To Use | true |
Device Is Sterile | true |
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
Ethylene Oxide
[B145113350]
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 |
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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 |