Integra® Miltex®
DUKE Trocar and Cannula
1manufacturer
6catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | FBQ |
| Device type | Trocar, Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5090 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-08-03 |
| Record revised | 2024-02-05 (version 6) |
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 | 2020-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 13-9 | Withdrawn | |
| 13-11 | Withdrawn | |
| 13-8 | Withdrawn | |
| 13-10 | Withdrawn | |
| 13-20 | Withdrawn | |
| 13-2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 62 |
| Riwo-ART | Richard Wolf Gmbh | 52 |
| Trocar, Gastro-Urology | Richard Wolf Gmbh | 43 |
| Doctor Nice | B. ALI Impex | 23 |
| MIP Minimal Invasive Pcnl | Karl Storz GmbH & Co. KG | 6 |
| Spring Grip | Covidien LP | 6 |
| Trotec | Richard Wolf Gmbh | 6 |
| Trocar, Gastro-Urology | Karl Storz GmbH & Co. KG | 5 |
| Cook | Cook Incorporated | 5 |
| EchoTip | Cook Incorporated | 3 |
| Strauss Surgical | American Medical Endoscopy | 3 |
| Mitty-Pollack | Cook Incorporated | 3 |
Showing 12 of 19. All products under Trocar, Gastro-Urology
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.