Integra®
Integra® Lichtwicz Antrum Trocar Needle, Beveled 18 Gauge
3manufacturers in China registered for this device type
7catalogue 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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | KTE |
| Device type | Trocar, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 874.4420 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-17 |
| Record revised | 2023-04-17 (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, manufacturing date |
| Distribution end date | 2022-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3714220 | In distribution | |
| 3714218 | In distribution | |
| 3714243 | In distribution | |
| 3714242 | In distribution | |
| 3714219 | In distribution | |
| 3714241 | In distribution | |
| 3714696 | Withdrawn |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 |
| Surtex | Surtex Instruments Ltd | 6 |
| V. Mueller | Steris Corporation | 6 |
| TraumaOne System | Biomet Microfixation | 4 |
| 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.