TraumaOne System
4 catalogue numbers from 46-0012, listed by Biomet Microfixation, United States, under Trocar, Ent. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
Record
| Listed by | Biomet Microfixation, United States |
|---|---|
| FDA product code | KTE |
| Device type | Trocar, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-07 |
| Record revised | 2025-05-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2020-07-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 46-0012 | In distribution | |
| 46-0013 | In distribution | |
| 46-0012 | Withdrawn | |
| 46-0013 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 15 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 14 |
| Aesculap | Aesculap AG | 10 |
| Integra® | Integra LifeSciences Production Corporation | 7 |
| Surtex | Surtex Instruments Ltd | 6 |
| V. Mueller | Steris Corporation | 6 |
| Boss Instruments | Boss Instruments, Ltd. | 4 |
| MicroFrance® | Integra Microfrance SAS | 4 |
| Antrum trocar, oblique beak | Spiggle & Theis Medizintechnik Gmbh | 3 |
| Pilling | Teleflex Medical LLC | 3 |
| Millennium | Avalign Technologies, Inc. | 3 |
| BI-Phase System | Biomet Microfixation | 2 |
Showing 12 of 28. All products under Trocar, Ent
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.