| Primary Device ID | 20851809002986 |
| NIH Device Record Key | 10af5f78-7bf3-497e-80a7-39efd4db4b22 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Oto Ease |
| Version Model Number | 93236 |
| Catalog Number | 93236 |
| Company DUNS | 828918164 |
| Company Name | HR PHARMACEUTICALS 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(717)252-1110 |
| chris.wiesman@hrpharma.com |
| Weight | 1 Gram |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851809002982 [Primary] |
| GS1 | 20851809002986 [Package] Contains: 00851809002982 Package: Case [1000 Units] In Commercial Distribution |
| KMJ | Lubricant, patient |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20851809002986]
Liquid Chemical
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-09-27 |
| Device Publish Date | 2018-08-27 |
| 20851809002986 | Sterile Lubricant, Packet |
| 20851809002979 | Sterile Lubricant, Bottle |
| 20851809002962 | Sterile Lubricant, Bottle |