| Primary Device ID | 00850071154450 |
| NIH Device Record Key | 15300822-e578-4227-a0e4-91af8b624d69 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Instrument Organizer |
| Version Model Number | CSDH512 |
| Company DUNS | 139362420 |
| Company Name | Hanes Companies, Inc. |
| Device Count | 100 |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850071154436 [Primary] |
| GS1 | 00850071154450 [Unit of Use] |
| MDM | Instrument, Manual, Surgical, General Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-12-08 |
| Device Publish Date | 2025-10-22 |
| 00850071154450 - Instrument Organizer | 2025-12-08 |
| 00850071154450 - Instrument Organizer | 2025-12-08 |
| 00850071154061 - Steri-Pocket | 2025-07-24 |
| 00850071154108 - Steri-Pocket | 2025-07-24 |
| 00850071154122 - Steri-Pocket | 2025-07-24 |
| 00850071154146 - Steri-Pocket | 2025-07-24 |
| 00850071154160 - Steri-Pocket | 2025-07-24 |
| 00850071154184 - Steri-Pocket | 2025-07-24 |
| 00850071154085 - Steri-Pocket | 2025-07-24 |