| Primary Device ID | 00850078230119 |
| NIH Device Record Key | 0e6b1cce-3cda-4ad9-b42c-0e8c27bc552e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Disruptive MedTech |
| Version Model Number | CUT-D28 |
| Company DUNS | 044831540 |
| Company Name | MAHE MEDICAL USA LLC |
| 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 | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8556243633 |
| complaints@mahemedical.com | |
| Phone | 8556243633 |
| complaints@mahemedical.com | |
| Phone | 8556243633 |
| complaints@mahemedical.com | |
| Phone | 8556243633 |
| complaints@mahemedical.com | |
| Phone | 8556243633 |
| complaints@mahemedical.com | |
| Phone | 8556243633 |
| complaints@mahemedical.com | |
| Phone | 8556243633 |
| complaints@mahemedical.com | |
| Phone | 8556243633 |
| complaints@mahemedical.com | |
| Phone | 8556243633 |
| complaints@mahemedical.com | |
| Phone | 8556243633 |
| complaints@mahemedical.com | |
| Phone | 8556243633 |
| complaints@mahemedical.com | |
| Phone | 8556243633 |
| complaints@mahemedical.com | |
| Phone | 8556243633 |
| complaints@mahemedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850078230119 [Primary] |
| FZT | Cutter, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00850078230119]
Moist Heat or Steam Sterilization
[00850078230119]
Moist Heat or Steam Sterilization
[00850078230119]
Moist Heat or Steam Sterilization
[00850078230119]
Moist Heat or Steam Sterilization
[00850078230119]
Moist Heat or Steam Sterilization
[00850078230119]
Moist Heat or Steam Sterilization
[00850078230119]
Moist Heat or Steam Sterilization
[00850078230119]
Moist Heat or Steam Sterilization
[00850078230119]
Moist Heat or Steam Sterilization
[00850078230119]
Moist Heat or Steam Sterilization
[00850078230119]
Moist Heat or Steam Sterilization
[00850078230119]
Moist Heat or Steam Sterilization
[00850078230119]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-22 |
| Device Publish Date | 2025-08-14 |
| 00850078230119 | Cutter, Round D28mm |
| 00850078230102 | Cutter, Round D15mm |
| 00850078230096 | Cutter, Oval 22x32mm |
| 00850078230089 | Cutter, Oval 20x25mm |
| 00850078230072 | Cutter, Oval 15x23mm |
| 00850078230065 | Cutter, Oval 13x20mm |
| 00850078230058 | Cutter, Rectangular 10x30mm |
| 00850078230041 | Mallet, 11.5x20mm head, 432g |
| 00850078230034 | Scissors, Iris Tungsten Carbide |
| 00850078230027 | Foreceps, Adson Toothless |
| 00850078230010 | Curette, 6.0mm Ring |
| 00850078230003 | Curette, 4.5mm Ring |