| Primary Device ID | 00840117338012 |
| NIH Device Record Key | 16e6d813-153d-4ea7-adbd-75117a774695 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Debridement Kit, Sterile |
| Version Model Number | 4150 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 00840117338005 [Package] Package: MC [50 Units] In Commercial Distribution |
| GS1 | 00840117338012 [Primary] |
| KDD | Kit, Surgical Instrument, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-26 |
| Device Publish Date | 2024-06-18 |
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