Primary Device ID | B14527750200U13SH1 |
NIH Device Record Key | bc29e2a9-4105-46cb-895f-91158c4b080e |
Commercial Distribution Discontinuation | 2017-03-28 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | FlexGuard Laser Fiber with Extended Length Sheath |
Version Model Number | 27750200U1SH |
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 | 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 |
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 | B14527750200U13SH1 [Package] Contains: B14527750200U1SH0 Package: box [3 Units] Discontinued: 2017-03-28 Not in Commercial Distribution |
HIBCC | B14527750200U1SH0 [Primary] |
GEX | Powered laser surgical instrument |
Steralize Prior To Use | true |
Device Is Sterile | true |
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
Ethylene Oxide
[B14527750200U13SH1]
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 |
B14527750300U13SH1 | 300 micrometer FlexGuard fiber with extended length sheath |
B14527750272U13SH1 | 272 micrometer FlexGuard fiber with extended length sheath |
B14527750200U13SH1 | 200 micrometer FlexGuard fiber with extended length sheath |