| Primary Device ID | 00616784436920 |
| NIH Device Record Key | 4052e0ed-2b3a-4571-8993-1dbdb511c3fe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cervical Collar |
| Version Model Number | 4369 |
| Company DUNS | 008124539 |
| Company Name | DYNAREX CORPORATION |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00616784436920 [Primary] |
| GS1 | 00616784436937 [Package] Package: [10 Units] In Commercial Distribution |
| IQK | Orthosis, Cervical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2022-06-10 |
| Device Publish Date | 2020-11-18 |
| 00616784436920 | Cervical Collar, Universal, 4" x 22" |
| 00616784436838 | Cervical Collar, Universal, 3.5" x 22" |
| 00616784436739 | Cervical Collar, Universal, 3" x 22" |
| 00616784436630 | Cervical Collar, Universal, 2.5" x 22" |
| 00616784436531 | Cervical Collar, X-Large, 3 3/4" High |
| 00616784436432 | Cervical Collar, Large, 3 3/4" High |
| 00616784436333 | Cervical Collar, Medium, 3 3/4" High |
| 00616784436234 | Cervical Collar, Small, 3 3/4" High |
| 00616784436135 | Cervical Collar, X-Small, 3 3/4" High |
| 00616784436036 | Cervical Collar, X-Large, 3" High |
| 00616784435930 | Cervical Collar, Large, 3" High |
| 00616784435831 | Cervical Collar, Medium, 3" High |
| 00616784435732 | Cervical Collar, Small, 3" High |
| 00616784435633 | Cervical Collar, X-Small, 3" High |