| Primary Device ID | 10841268109091 |
| NIH Device Record Key | c3baa28c-c8f6-4c1d-926e-1e3f1b1a1a2f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | M-Drain® Centesis Catheter |
| Version Model Number | DRC-011-02 |
| Catalog Number | D40104010 |
| Company DUNS | 943156836 |
| Company Name | GALT MEDICAL CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| 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 |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268109094 [Primary] |
| GS1 | 10841268109091 [Package] Contains: 00841268109094 Package: Shelf Box [10 Units] In Commercial Distribution |
| GS1 | 20841268109098 [Package] Package: Shipper Box [100 Units] In Commercial Distribution |
| KGZ | Accessories, Catheter |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
[10841268109091]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-15 |
| Device Publish Date | 2020-12-07 |
| 10841268109145 | M-Drain® Centesis Catheter |
| 10841268109138 | M-Drain® Centesis Catheter |
| 10841268109121 | M-Drain® Centesis Catheter |
| 10841268109114 | M-Drain® Centesis Catheter |
| 10841268109107 | M-Drain® Centesis Catheter |
| 10841268109091 | M-Drain® Centesis Catheter |
| 10841268109084 | M-Drain® Centesis Catheter |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() M-DRAIN 79176795 5051833 Live/Registered |
Mermaid Medical A/S 2015-09-28 |