| Primary Device ID | 20841268108435 |
| NIH Device Record Key | 86008381-8ea2-4dcd-95e8-f429b4c65e51 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MicroIntroducer 3Fr x 7cm ELITE HV |
| Version Model Number | CLI-136-00 |
| Catalog Number | CLI-136-00 |
| Company DUNS | 943156836 |
| Company Name | GALT MEDICAL CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| Phone | 800-639-2800 |
| customerservice@galtneedletech.com |
| Catheter Gauge | 3 French |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841268108431 [Primary] |
| GS1 | 10841268108438 [Package] Contains: 00841268108431 Package: Shelf Box [10 Units] In Commercial Distribution |
| GS1 | 20841268108435 [Package] Contains: 10841268108438 Package: Shipper Box [100 Units] In Commercial Distribution |
| DYB | Introducer, Catheter |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20841268108435]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2019-05-23 |
| 10841268110059 - Micro-Introducer Kit | 2026-01-27 Micro-Introducer Kit |
| 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 |