| Primary Device ID | 04052838009423 |
| NIH Device Record Key | 986aa13a-0749-44a9-88f5-61757fe3d0a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Injectra, ScleroTip |
| Version Model Number | GSN-01-19-230 |
| Catalog Number | GSN-01-19-230 |
| Company DUNS | 318130267 |
| Company Name | Medi-Globe 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 | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | +4980329730 |
| sales@medi-globe.de |
| Needle Gauge | 22 Gauge |
| Special Storage Condition, Specify | Between 0 and 0 *keep dry, keep away from sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04052838009416 [Primary] |
| GS1 | 04052838009423 [Package] Contains: 04052838009416 Package: box [10 Units] In Commercial Distribution |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-06-14 |
| 04052838009560 | Injection Needle / Sclerotherapy Needle, 22 Gauge, needle length 6 mm, tube diameter 1.9 mm, wor |
| 04052838009423 | Injection Needle / Slerotherapy Needle , 22 Gauge, needle length 4 mm, tube diameter 1.9 mm, wor |