Primary Device ID | B145111430 |
NIH Device Record Key | eaad6dd9-162c-4a1e-a3c5-483907e3d278 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ScopeSafe™Laser Fiber with ScopeGuardian™ Sheath |
Version Model Number | 11143 |
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 |
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 |
Device Size Text, specify | 0 |
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 | B145111430 [Primary] |
HIBCC | B145111431 [Package] Package: box [3 Units] In Commercial Distribution |
GEX | Powered laser surgical instrument |
Steralize Prior To Use | true |
Device Is Sterile | true |
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
Ethylene Oxide
[B145111430]
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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B145113680 | 272 micrometer ScopeSafe laser fiber with Sheath and Y adapter |
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B145111430 | 272 micrometer ScopeSafe laser fiber with ScopeGuardian Sheath |
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