| Primary Device ID | 00616784562926 |
| NIH Device Record Key | cda954a4-7a54-4a9f-a66c-f89847c53544 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Basic, Quick-Release Head Immobilizer |
| Version Model Number | 5629 |
| Company DUNS | 008124539 |
| Company Name | DYNAREX CORPORATION |
| Device Count | 5 |
| 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 | true |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00616784562926 [Unit of Use] |
| GS1 | 00616784562933 [Primary] |
| MRI | Orthosis, Truncal/Orthosis, Limb |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-09-09 |
| Device Publish Date | 2021-09-01 |
| 00840117340718 - Biopsy Punch, Sterile, 3.0 mm Grey | 2025-04-08 STERILE-R |
| 00840117340725 - Biopsy Punches, Sterile, 3.5 mm, Yellow | 2025-04-08 STERILE-R |
| 00840117340732 - Biopsy Punches, Sterile, 4.0 mm, Blue | 2025-04-08 STERILE-R |
| 00840117340862 - Biopsy Punches, Sterile, 5.0 mm, Pink | 2025-04-08 STERILE-R |
| 00840117340879 - Biopsy Punches, Sterile, 6.0 mm, Light Green | 2025-04-08 STERILE-R |
| 00840117340923 - Biopsy Punches, Sterile, 8.0 mm, Purple | 2025-04-08 |
| 00840117340930 - Biopsy Punches, Sterile, Mixed Box | 2025-04-08 Biopsy Punches, Sterile, Mixed Box, 5 each of 2.0 mm, 3.0 mm, 4.0 mm, 5.0 mm, 6.0 mm |
| 00810180841665 - LabChoice Specimen Bags, 6" x 9", 1.8 MIL, Non-Sterile | 2025-04-07 |