| Primary Device ID | 00810126041791 |
| NIH Device Record Key | fd513f75-d286-44ef-83a8-d80ca6e93c27 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MARTFIT BONE REDUCTION GUIDE 10 HOLES |
| Version Model Number | ETSGBR10 |
| Company DUNS | 796083090 |
| Company Name | HIOSSEN, INC. |
| 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 | true |
| Manufacturing Date | true |
| 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 | 00810126041791 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-09 |
| Device Publish Date | 2025-04-01 |
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| 00810126043481 - ET III Fixture NH Regular Pre-Mounted | 2025-10-07 |