| Primary Device ID | 4052838014151 |
| NIH Device Record Key | c90f2ae3-83d4-4f58-939f-5318df02715c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SonoTip Pro Control |
| Version Model Number | GUS-33-18-022-04 |
| Catalog Number | GUS-33-18-022-04 |
| 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 *Please store the instrument at room temperature, keep dry and avoid exposure to sunlight |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04052838014144 [Primary] |
| GS1 | 4052838014151 [Package] Contains: 04052838014144 Package: Box [10 Units] In Commercial Distribution |
| FCG | Biopsy Needle |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[4052838014151]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-12-21 |
| Device Publish Date | 2016-09-23 |
| 4052838014151 | SonoTip ProControl Endoscopic Ultrasound Needle, EUS-FNA, 22 G, Needle Length 0 - 8.5 cm, Sheath |
| 4052838014137 | SonoTip Pro Control Endoscopic Ultrasound Needle, EUS-FNA, 22 G, Needle Length 0 - 8.5 cm, Sheat |
| 4052838014113 | SonoTip Pro Control Endoscopic Ultrasound Needle, EUS-FNA, 22 G, Needle Length 0 - 8.5 cm, Sheat |
| 4052838014090 | SonoTip Pro Control Endoscopic Ultrasound Needle, EUS-FNA, 25 G, Needle Length 0 - 8.5 cm, Sheat |
| 4052838014076 | SonoTip Pro Control Endoscopic Ultrasound Needle, EUS-FNA, 22 G, Needle Length 0 - 8.5 cm, Sheat |
| 4052838014052 | SonoTip ProControl Endoscopic Ultrasound Needle, EUS-FNA, 19 G, Needle Length 0 - 8.5 cm, Sheath |
| 4052838014038 | SonoTip ProControl Endoscopic Ultrasound Needle, EUS-FNA, 25 G, Needle Length 0 - 8.5 cm, Sheath |