| Primary Device ID | 05907996096169 |
| NIH Device Record Key | 470e447d-a644-48fe-a58d-9ecd0215a12e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MICRON, droplet pen needle |
| Version Model Number | 34G x 3.5mm |
| Catalog Number | 7915 |
| Company DUNS | 422528088 |
| Company Name | HTL STREFA S A |
| Device Count | 5 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1-770-528-0410 |
| info@mydroplet.com |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05907996096169 [Primary] |
| GS1 | 15907996096166 [Package] Package: case [40 Units] In Commercial Distribution |
| GS1 | 25907996096163 [Package] Contains: 15907996096166 Package: shipper [12 Units] In Commercial Distribution |
| GS1 | 85907996096165 [Unit of Use] |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-03 |
| Device Publish Date | 2020-01-24 |
| 05907996096169 | Sterile, single use MICRON, droplet pen needles, intended to be used with a pen injector device |
| 05907996096152 | Sterile, single use MICRON, droplet pen needles, intended to be used with a pen injector device |