Primary Device ID | 10841268109176 |
NIH Device Record Key | a8c15d83-5bcd-4799-9124-e78b5c9605aa |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Hydrophilic M-Drain® Introducer Kit |
Version Model Number | KIT-089-02 |
Catalog Number | DS2010300 |
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 | 00841268109179 [Primary] |
GS1 | 10841268109176 [Package] Contains: 00841268109179 Package: Shelf Box [10 Units] In Commercial Distribution |
GS1 | 20841268109173 [Package] Package: Shipper Box [100 Units] In Commercial Distribution |
OFL | Percutaneous Sheath Introducer Kit |
Steralize Prior To Use | true |
Device Is Sterile | true |
[10841268109176]
Ethylene Oxide
[10841268109176]
Ethylene Oxide
[10841268109176]
Ethylene Oxide
[10841268109176]
Ethylene Oxide
[10841268109176]
Ethylene Oxide
[10841268109176]
Ethylene Oxide
[10841268109176]
Ethylene Oxide
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Ethylene Oxide
[10841268109176]
Ethylene Oxide
[10841268109176]
Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
[10841268109176]
Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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Ethylene Oxide
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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 |