| Primary Device ID | 30884908016902 |
| NIH Device Record Key | 307f54a8-c045-400f-9e31-b2c5fb304d24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIRE |
| Version Model Number | G130N |
| Catalog Number | G130N |
| Company DUNS | 038000253 |
| Company Name | Medical Components, Inc. |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 | +1(215)256-4201 |
| clinical@medcompnet.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00884908016901 [Primary] |
| GS1 | 30884908016902 [Package] Contains: 00884908016901 Package: inner box [10 Units] In Commercial Distribution |
| GS1 | 50884908016906 [Package] Package: box [4 Units] In Commercial Distribution |
| DQX | Wire, guide, catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-05-06 |
| Device Publish Date | 2018-10-06 |
| 30884908105279 | 0.010" (0.26MM) X 40CM0.010" (0. NITINOL GUIDEWIRENITINOL GUIDEWI |
| 50884908105259 | 0.010 (0.26MM) X 20CM0.010 (0.26 NITINOL GUIDEWIRENITINOL GUIDEWI |
| 30884908016902 | 0.018" (0.46MM) X 130CM NITINOL GUIDEWIRE W/ RADIOPAQUE TIP |