M-Drain® Centesis Catheter D40105007
GUDID 10841268109114
M-Drain® Centesis Catheter
GALT MEDICAL CORP.
Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable Closed-wound drain, non-bioabsorbable| Primary Device ID | 10841268109114 |
| NIH Device Record Key | ee481436-0be5-4a76-a8d8-c1c174adb448 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | M-Drain® Centesis Catheter |
| Version Model Number | DRC-011-05 |
| Catalog Number | D40105007 |
| 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 |
Customer Support Contacts
Device Dimensions
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
| Catheter Gauge | 5 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268109117 [Primary] |
| GS1 | 10841268109114 [Package] Contains: 00841268109117 Package: Shelf Box [10 Units] In Commercial Distribution |
| GS1 | 20841268109111 [Package] Package: Shipper Box [100 Units] In Commercial Distribution |
FDA Product Code
| KGZ | Accessories, Catheter |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
[10841268109114]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-15 |
| Device Publish Date | 2020-12-07 |
On-Brand Devices [M-Drain® Centesis Catheter]
| 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 |
Trademark Results [M-Drain]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 M-DRAIN 79176795 5051833 Live/Registered |
Mermaid Medical A/S 2015-09-28 |
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