| Primary Device ID | 10841268109602 |
| NIH Device Record Key | 066a3e53-92db-4a5c-bdea-d044a152e209 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 4F x 60cm Micro-Introducer Kit |
| Version Model Number | CLI-131-60 |
| Catalog Number | INT0460 |
| 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 | 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 |
| Catheter Gauge | 4 French |
| Catheter Gauge | 4 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268109605 [Primary] |
| GS1 | 10841268109602 [Package] Contains: 00841268109605 Package: Shelf Box [10 Units] In Commercial Distribution |
| GS1 | 20841268109609 [Package] Package: Shipper Box [50 Units] In Commercial Distribution |
| OFL | Percutaneous Sheath Introducer Kit |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
[10841268109602]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-08 |
| Device Publish Date | 2021-10-29 |
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| 10841268110066 - Guidewire | 2026-01-27 Guidewire |
| 10841268110073 - Hemostasis Valve Adapter | 2026-01-27 Hemostasis Valve Adapter |
| 10841268110080 - Guidewire | 2026-01-27 Guidewire |
| 10841268110097 - TVS LPA | 2026-01-27 TVS LPA |
| 10841268110110 - Guidewire | 2026-01-27 Guidewire |
| 10841268110127 - TVS LPA | 2026-01-27 TVS LPA |
| 10841268110141 - Dilator | 2026-01-27 Dilator |