| Primary Device ID | 10850013266248 |
| NIH Device Record Key | b8c2162d-fd0a-4847-b7ec-eb61e2701c20 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hummingbird |
| Version Model Number | CK 42 |
| Company DUNS | 056999617 |
| Company Name | IRRAS USA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850013266241 [Primary] |
| GS1 | 10850013266248 [Package] Contains: 00850013266241 Package: [6 Units] In Commercial Distribution |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-23 |
| Device Publish Date | 2023-10-13 |
| 10850013266248 | IC42 Cranial Access Kit |
| 10850013266231 | IC 40 Cranial Access Kit |