| Primary Device ID | M711LS24280 |
| NIH Device Record Key | 12e772e8-c6a1-4d1a-b165-199f9ee8084a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Px® |
| Version Model Number | LS-242-8 |
| Catalog Number | LS-242-8 |
| Company DUNS | 141620464 |
| Company Name | INNO Holdings, Inc. |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com | |
| Phone | 801-261-2236 |
| info@innovasis.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M711LS24280 [Primary] |
| FZO | Chisel, Surgical, Manual |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M711LS24280]
Moist Heat or Steam Sterilization
[M711LS24280]
Moist Heat or Steam Sterilization
[M711LS24280]
Moist Heat or Steam Sterilization
[M711LS24280]
Moist Heat or Steam Sterilization
[M711LS24280]
Moist Heat or Steam Sterilization
[M711LS24280]
Moist Heat or Steam Sterilization
[M711LS24280]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-12-17 |
| Device Publish Date | 2018-08-13 |
| M711LS24290 | SST |
| M711LS24280 | SST |
| M711LS242160 | SST |
| M711LS242150 | SST |
| M711LS242140 | SST |
| M711LS242130 | SST |
| M711LS242120 | SST |
| M711LS242110 | SST |
| M711LS242100 | SST |
| M711BTA900 | Implant Caddy, Px, 8mm x 25mm, 5°, Polypropylene, Radel, SST |