Primary Device ID | B145114891 |
NIH Device Record Key | 3bb01190-4965-4917-ae19-fc463a70f7c5 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | StripRight |
Version Model Number | 11388 |
Company DUNS | 024050887 |
Company Name | OPTICAL INTEGRITY INC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 |
Phone | +1(850)233-5512 |
customercare@opticalintegrity. | |
Phone | +1(850)233-5512 |
customercare@opticalintegrity. |
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 | B145113880 [Primary] |
HIBCC | B145114891 [Package] Contains: B145113880 Package: box [5 Units] In Commercial Distribution |
HRT | STRIPPER, SURGICAL |
Steralize Prior To Use | true |
Device Is Sterile | true |
[B145114891]
Ethylene Oxide
[B145114891]
Ethylene Oxide
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-11-03 |
B145114921 | 1000 µm StripRight Fiber Strip and Scribe Tool |
B145114891 | 550 µm StripRight Fiber Strip and Scribe Tool |
B14514861 | 365 µm StripRight Fiber Strip and Scribe Tool |
B145114831 | 300 µm StripRight Fiber Strip and Scribe Tool |
B145114801 | 272 µm StripRight Fiber Strip and Scribe Tool |
B145114771 | 200 µm StripRight Fiber Strip and Scribe Tool |