| Primary Device ID | 04046963412791 |
| NIH Device Record Key | 96c5eea0-07ac-4129-8a66-62de464e374c |
| Commercial Distribution Discontinuation | 2023-10-02 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | one.click needle |
| Version Model Number | U1244101 |
| Catalog Number | 16440EMD |
| Company DUNS | 088514898 |
| Company Name | EMD SERONO, INC. |
| Device Count | 100 |
| 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 | false |
| 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 |
| 04046964756290 - Pencylcap needle | 2024-09-11 Needles for use with compatible needle-based injection systems for subcutaneous
injection of fluid drug products. Single packed, |
| 04046963412791 - one.click needle | 2023-10-03Needles for one.click® auto-injector. Single packed, sterile. For single use only. Non-pyrogenic. |
| 04046963412791 - one.click needle | 2023-10-03 Needles for one.click® auto-injector. Single packed, sterile. For single use only. Non-pyrogenic. |
| 04046963413880 - Serofine needles 29 G | 2019-04-19 Needles for easypod auto-injector. Single packed, sterile. For single use only. Non-pyrogenic. |
| 04046963414047 - Serofine needles 30G | 2019-04-19 Needles for easypod auto-injector. Single packed, sterile. For single use only. Non-pyrogenic. |
| 04054839025792 - one.click | 2019-04-19 one.click is a mechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rNDA origin]) in c |
| 04054839025860 - easypod | 2019-04-19 easypod is an electromechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rDNA origin] |
| 04054839025808 - Rebiject II | 2018-03-29 Rebiject II® autoinjector is a device intended for automating subcutaneous injection of Rebif® (interferon beta-1a) in pre-fil |
| 04054839025914 - Clip-on Spacers for Rebif | 2018-03-29 Titration Clip for Dose Titration using Rebif® 22 mcg or 44 mcg Pre-filled Syringe. |