| Primary Device ID | 00866614000177 |
| NIH Device Record Key | 99cede43-4c8f-4802-a4e2-5cd3ac670539 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Precision Tunneler - Large |
| Version Model Number | 41.020.503 |
| Catalog Number | 41.020.503 |
| Company DUNS | 078846878 |
| Company Name | ARKIS BIOSCIENCES INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00866614000177 [Primary] |
| GYK | Instrument, Shunt System Implantation |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-14 |
| Device Publish Date | 2018-12-13 |
| 10866614000181 - Subcutaneous Guidewire - Medium | 2022-05-23 The Subcutaneous Guidewire is designed to facilitate the subcutaneous passage of tubing, suture, ribbons, and/or bands between t |
| 10866614000198 - Subcutaneous Guidewire - Large | 2022-05-23 The Subcutaneous Guidewire is designed to facilitate the subcutaneous passage of tubing, suture, ribbons, and/or bands between t |
| 10866614000105 - CerebroFlo EVD Catheter Set | 2019-11-01 The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain |
| 00866614000115 - Galea Elevator | 2019-05-03 The Galea Elevator is a stainless-steel, reusable, manual surgical instrument designed to retract and elevate scalp tissue. |
| 00866614000122 - Single Pass Tunneling Guidewire - Large | 2019-01-14 The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage of shunt tubing from a frontal scalp |
| 00866614000139 - Single Pass Tunneling Guidewire - Medium | 2019-01-14 The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage of shunt tubing from a frontal scalp |
| 00866614000146 - Single Pass Tunneling Guidewire - Small | 2019-01-14 The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage of shunt tubing from a frontal scalp |
| 00866614000153 - Precision Tunneler - Small | 2019-01-14 The Arkis Precision Tunneler is designed to facilitate the subcutaneous passage of shunt tubing between two skin incisions when |