| Primary Device ID | 08717903490525 |
| NIH Device Record Key | f6ec33e5-59a2-4afd-afd5-d2b0563ead1e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | D100 dermatome instrument organizer |
| Version Model Number | 4.D100IO |
| Catalog Number | 4.D100IO |
| Company DUNS | 489831498 |
| Company Name | Humeca B.V. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 | 08717903490525 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-27 |
| Device Publish Date | 2025-08-19 |
| 08717903490501 - D100 dermatome set | 2025-08-27 |
| 08717903490525 - D100 dermatome instrument organizer | 2025-08-27 |
| 08717903490525 - D100 dermatome instrument organizer | 2025-08-27 |
| 08717903490570 - Humeca D100 Dermatome blade | 2025-08-27 |
| 08717903492352 - Micrograft gauze + cork plate, 1:3, 5-pack | 2025-05-28 |
| 08717903495421 - Humeca D42 Dermatome blade | 2025-05-28 |
| 08717903495414 - Humeca blade for Padgett® model B, C and S dermatome | 2025-05-28 |
| 08717903495407 - Humeca blade for Aesculap®/Acculan® dermatome | 2025-05-28 |
| 08717903495445 - Humeca blade for Zimmer® 8801-8821 dermatome | 2025-05-28 |