| Primary Device ID | 08800038060326 |
| NIH Device Record Key | 9cfff5d0-bb14-4e52-a846-bd76f5b7d576 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EZImpactor |
| Version Model Number | BMA-P10-S01 |
| Company DUNS | 690340653 |
| Company Name | IMEDICOM CO., LTD. |
| 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 | false |
| Lot Batch | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800038060326 [Primary] |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08800038060326]
Moist Heat or Steam Sterilization
[08800038060326]
Moist Heat or Steam Sterilization
[08800038060326]
Moist Heat or Steam Sterilization
[08800038060326]
Moist Heat or Steam Sterilization
[08800038060326]
Moist Heat or Steam Sterilization
[08800038060326]
Moist Heat or Steam Sterilization
[08800038060326]
Moist Heat or Steam Sterilization
[08800038060326]
Moist Heat or Steam Sterilization
[08800038060326]
Moist Heat or Steam Sterilization
[08800038060326]
Moist Heat or Steam Sterilization
[08800038060326]
Moist Heat or Steam Sterilization
[08800038060326]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-30 |
| Device Publish Date | 2026-01-22 |
| 08800038060340 | EZImpactor |
| 08800038060333 | EZImpactor |
| 08800038060326 | EZImpactor |
| 08800038060319 | EZImpactor |