Primary Device ID | B14527750940U131 |
NIH Device Record Key | 2e9bf476-d2b0-4b6b-827d-2c8b18a2f9cd |
Commercial Distribution Discontinuation | 2017-03-28 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | ScopeSafe™Laser Fiber |
Version Model Number | 27750940U1 |
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 | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 940 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 | B14527750940U10 [Primary] |
HIBCC | B14527750940U131 [Package] Contains: B14527750940U10 Package: box [3 Units] Discontinued: 2017-03-28 Not in Commercial Distribution |
GEX | Powered laser surgical instrument |
Steralize Prior To Use | true |
Device Is Sterile | true |
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
Ethylene Oxide
[B14527750940U131]
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 |
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B145P00120300SS0 | 300 micrometer ScopeSafe laser fiber |
B145P00120272SS0 | 272 micrometer ScopeSafe laser fiber |
B145P00120200SS0 | 200 micrometer ScopeSafe laser fiber |
B14527750940U131 | 940 micrometer ScopeSafe laser fiber |
B14527750550U131 | 550 micrometer ScopeSafe laser fiber |
B14527750365U131 | 365 micrometer ScopeSafe laser fiber |
B14527750300U131 | 300 micrometer ScopeSafe laser fiber |
B14527750272U131 | 272 micrometer ScopeSafe laser fiber |
B14527750200U131 | 200 micrometer ScopeSafe laser fiber |
B145112110 | 200 micrometer ScopeSafe laser fiber with Sheath |
B145109660 | 272 micrometer ScopeSafe laser fiber with 895mm length Sheath |
B145109041 | 300 micrometer ScopeSafe laser fiber |
B145108500 | 1000 micrometer ScopeSafe laser fiber, Convergent compatible, reusable |
B145108490 | 550 micrometer ScopeSafe laser fiber, Convergent compatible, reusable |
B145108480 | 365 micrometer ScopeSafe laser fiber, Convergent compatible, reusable |
B145108470 | 300 micrometer ScopeSafe laser fiber, Convergent compatible, reusable |
B145108460 | 272 micrometer ScopeSafe laser fiber, Convergent compatible, reusable |
B145108420 | 300 micrometer ScopeSafe laser fiber, Trimedyne compatible |
B145108410 | 272 micrometer ScopeSafe laser fiber, Trimedyne compatible |
B145108400 | 200 micrometer ScopeSafe laser fiber, Trimedyne compatible |
B145107280 | 272 micrometer ScopeSafe laser fiber with extension sleeve, reusable |
B145107190 | 300 micrometer ScopeSafe laser fiber with Sheath |
B145106830 | 272 micrometer ScopeSafe laser fiber with Sheath |
B145106810 | 200 micrometer ScopeSafe laser fiber with Sheath |
B145106450 | 200 micrometer ScopeSafe laser fiber, 4m length |
B145106260 | 300 micrometer ScopeSafe laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve |
B145106250 | 272 micrometer ScopeSafe laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve |
B145105910 | 300 micrometer ScopeSafe laser fiber with extension sleeve |
B145105600 | 272 micrometer ScopeSafe laser fiber with extension sleeve |
B145103880 | 300 micrometer ScopeSafe laser fiber reusable |
B145103831 | 940 micrometer ScopeSafe laser fiber |
B145103821 | 550 micrometer ScopeSafe laser fiber |
B145103811 | 365 micrometer ScopeSafe laser fiber |
B145103801 | 272 micrometer ScopeSafe laser fiber |
B145103791 | 200 micrometer ScopeSafe laser fiber |
B145102360 | 200 micrometer ScopeSafe laser fiber |
B145102120 | 300 micrometer ScopeSafe laser fiber |
B145102110 | 272 micrometer ScopeSafe laser fiber |