| Primary Device ID | 10841268109183 |
| NIH Device Record Key | ba2a4725-ad68-4eb3-b2d1-16343d14a3b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hydrophilic M-Drain® Introducer Kit |
| Version Model Number | KIT-089-03 |
| Catalog Number | DS2010400 |
| 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 | true |
| 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 | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Catheter Gauge | 6 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268109186 [Primary] |
| GS1 | 10841268109183 [Package] Contains: 00841268109186 Package: Shelf Box [10 Units] In Commercial Distribution |
| GS1 | 20841268109180 [Package] Package: Shipper Box [100 Units] In Commercial Distribution |
| OFL | Percutaneous Sheath Introducer Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
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Ethylene Oxide
[10841268109183]
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[10841268109183]
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[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
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Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
[10841268109183]
Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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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 |
| 10841268109183 | Hydrophilic M-Drain® Introducer Kit |
| 10841268109176 | Hydrophilic M-Drain® Introducer Kit |
| 10841268109169 | Hydrophilic M-Drain® Introducer Kit |
| 10841268109152 | Hydrophilic M-Drain® Introducer Kit |