| Primary Device ID | 07613252186977 |
| NIH Device Record Key | d625b579-8fe5-4b84-af3b-477c559cf792 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FASTRACKER - 18 |
| Version Model Number | M0031341100 |
| Catalog Number | 134110 |
| Company DUNS | 042405446 |
| Company Name | Stryker Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(855)916-3876 |
| NVCustomerService@stryker.com |
| Device Size Text, specify | 0 |
| Length | 175 Centimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Store in cool, dry, dark place |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613252186977 [Primary] |
| DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-03-21 |
| Device Publish Date | 2016-09-21 |
| 07613327601138 - OptaBlate | 2025-04-25 Curve 10mm Probe Single Kit |
| 07613327601145 - OptaBlate | 2025-04-25 Curve 20mm Probe Single Kit |
| 07613327601152 - OptaBlate | 2025-04-25 Curve 15mm Probe Single Kit |
| 07613327631883 - OptaBlate | 2025-04-25 Straight 10MM Probe Dual Kit |
| 07613327631890 - OptaBlate | 2025-04-25 Straight 10MM Probe Single Kit |
| 07613327626391 - ThermaClear | 2025-04-14 |
| 07613327626407 - ThermaClear | 2025-04-14 |
| 07613327626469 - ThermaClear | 2025-04-14 |