4 catalogue numbers from 72-1010, listed by Biomet Microfixation, United States, under Motor, Surgical Instrument, Ac-Powered. 7 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (5), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for IQ System | Listed by | Biomet Microfixation, United States |
| FDA product code | GEY |
| Device type | Motor, Surgical Instrument, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-06-18 |
| Record revised | 2025-05-30 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2020-07-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.