| Primary Device ID | B145114801 |
| NIH Device Record Key | 31c78798-d9a8-4fb4-9df6-7a309742741d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | StripRight |
| Version Model Number | 11382 |
| 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. |
| 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 | B145113820 [Primary] |
| HIBCC | B145114801 [Package] Contains: B145113820 Package: box [5 Units] In Commercial Distribution |
| HRT | STRIPPER, SURGICAL |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[B145114801]
Ethylene Oxide
[B145114801]
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 |