Primary Device ID | B145110921 |
NIH Device Record Key | 6dcea7a3-f070-4c6e-b6c2-55d4285680ab |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Flex-G Fiber with Sheath Calculase compatible |
Version Model Number | 11090 |
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 | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 Micrometer |
Device Size Text, specify | 0 |
Outer Diameter | 200 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 | B145110900 [Primary] |
HIBCC | B145110921 [Package] Contains: B145110900 Package: box [3 Units] In Commercial Distribution |
GEX | Powered laser surgical instrument |
Steralize Prior To Use | true |
Device Is Sterile | true |
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
[B145110921]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-12-19 |
B145111001 | 300 micrometer Flex-G Fiber with Sheath Calculase compatible |
B145110961 | 272 micrometer Flex-G Fiber with Sheath Calculase compatible |
B145110921 | 200 micrometer Flex-G Fiber with Sheath Calculase compatible |