| Primary Device ID | 47612799222856 |
| NIH Device Record Key | ec9efa49-3460-4fa9-bb09-885210b01193 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Omnitrope Pen 10 |
| Version Model Number | 49041459 |
| Company DUNS | 300220969 |
| Company Name | Sandoz GmbH |
| 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 | true |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 47612799222856 [Direct Marking] |
| GS1 | 57612799210546 [Primary] |
| GS1 | 57622436000010 [Primary] |
| NSC | Injector, Pen |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-04-03 |
| Device Publish Date | 2023-02-07 |
| 49002269218553 | The Omnitrope Pen 10 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pe |
| 47612799222856 | The Omnitrope Pen 10 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pe |