| Primary Device ID | 07613327402100 |
| NIH Device Record Key | 87b86b2d-b933-46dd-8a09-a7517984d77c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Irvine Biomdeical Inc. |
| Version Model Number | D87022 |
| Catalog Number | D087022 |
| Company DUNS | 020198912 |
| Company Name | STRYKER SUSTAINABILITY SOLUTIONS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| 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(888)888-3433 |
| RegulatoryAffairs2@stryker.com |
| Length | 110 Centimeter |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07613327402100 [Primary] |
| NLH | CATHETER, RECORDING, ELECTRODE, REPROCESSED |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-11-03 |
| 57613327586560 - N/A | 2024-03-12 Ultrasonic Scalpel Shears with Advanced Hemostasis |
| 57613327586584 - N/A | 2024-03-12 Ultrasonic Scalpel Shears with Advanced Hemostasis |
| 07613327634150 - N/A | 2024-01-29 |
| 07613327465822 - N/A | 2023-12-08 |
| 07613327515183 - N/A | 2023-12-08 |
| 07613327601244 - N/A | 2023-06-09 EP Catheter Cable, 20 pin |
| 07613327601190 - N/A | 2023-02-24 EP Diagnostic Catheter, 22 pins |
| 07613327601251 - N/A | 2023-02-24 EP Catheter Cable, 34 Pin |