| Primary Device ID | 10868643000460 |
| NIH Device Record Key | f697a000-0952-45d3-8571-ddbee8a99b5f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IRRAflow Laser Leveler Package |
| Version Model Number | ICLS 010 |
| Catalog Number | ICLS 010 |
| Company DUNS | 056999617 |
| Company Name | Irras USA, 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00868643000463 [Primary] |
| GS1 | 10868643000460 [Package] Contains: 00868643000463 Package: Each [1 Units] In Commercial Distribution |
| GS1 | 20868643000467 [Package] Contains: 00868643000463 Package: Case [1 Units] In Commercial Distribution |
| JXG | Shunt, Central Nervous System And Components |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-18 |
| Device Publish Date | 2024-06-10 |
| 10850013266279 - IRRAflow Cranial Access Bolt | 2025-08-01 The IRRAflow Cranial Access Bolt is a single use, single-lumen bolt intended for use with the IRRAflow Dual Lumen Catheter to se |
| 00850013266258 - IRRAflow Catheter 2.0+ | 2025-05-15 IRRAflow Catheter 2.0+ intended for use with the IRRAflow Active Fluid Exchange System |
| 10868643000460 - IRRAflow Laser Leveler Package | 2024-06-18 |
| 10868643000460 - IRRAflow Laser Leveler Package | 2024-06-18 |