| Primary Device ID | 00812559010115 |
| NIH Device Record Key | 7219b8e8-dbcc-454d-8d69-656baa1fb4a2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ocu-Film + |
| Version Model Number | 230651 |
| Company DUNS | 126650253 |
| Company Name | REICHERT, 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-888-849-8955 |
| reichert.information@ametek.com | |
| Phone | 1-888-849-8955 |
| reichert.information@ametek.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812559010115 [Primary] |
| HKY | Tonometer, Manual |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
| 00812559012096 | Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer fr |
| 00812559012089 | Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer fr |
| 00812559010115 | Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer fr |