| Primary Device ID | 10841268109251 |
| NIH Device Record Key | ded7a6af-2737-4231-bd7c-018dfc9cb765 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Micro-Access Tearaway Introducer Kit |
| Version Model Number | KIT-042-09 |
| Catalog Number | 367571 |
| 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 | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Catheter Gauge | 9 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268109254 [Primary] |
| GS1 | 10841268109251 [Package] Contains: 00841268109254 Package: Shelf Box [5 Units] In Commercial Distribution |
| GS1 | 20841268109258 [Package] Package: Shipper Box [50 Units] In Commercial Distribution |
| OFL | Percutaneous Sheath Introducer Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
Ethylene Oxide
[10841268109251]
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 |
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| 20841268105342 | Micro-Access Tearaway Introducer Kit |
| 20841268105335 | Micro-Access Tearaway Introducer Kit |
| 20841268105328 | Micro-Access Tearaway Introducer Kit |
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| 20841268105304 | Micro-Access Tearaway Introducer Kit |
| 20841268105298 | Micro-Access Tearaway Introducer Kit |
| 20841268105281 | Micro-Access Tearaway Introducer Kit |
| 20841268105274 | Micro-Access Tearaway Introducer Kit |
| 20841268105267 | Micro-Access Tearaway Introducer Kit |
| 20841268105250 | Micro-Access Tearaway Introducer Kit |
| 20841268105243 | Micro-Access Tearaway Introducer Kit |
| 20841268105236 | Micro-Access Tearaway Introducer Kit |
| 20841268105229 | Micro-Access Tearaway Introducer Kit |
| 20841268105212 | Micro-Access Tearaway Introducer Kit |
| 20841268105205 | Micro-Access Tearaway Introducer Kit |
| 20841268105199 | Micro-Access Tearaway Introducer Kit |
| 20841268105182 | Micro-Access Tearaway Introducer Kit |
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| 10841268109244 | Micro-Access Tearaway Introducer Kit |
| 10841268109237 | Micro-Access Tearaway Introducer Kit |
| 10841268109220 | Micro-Access Tearaway Introducer Kit |
| 10841268109213 | Micro-Access Tearaway Introducer Kit |
| 10841268109206 | Micro-Access Tearaway Introducer Kit |