Laparoscope, Gynecologic (And Accessories)
TROCAR SLEEVE CAP 2.5MM WL 55MM stainless steel-sheath tube smooth, distal tip straight, with rubber cap, with insufflation valve, reusable
7manufacturers in China registered for this device type
37catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
Record
| Listed by | Richard Wolf Gmbh, Germany |
|---|---|
| FDA product code | HET |
| Device type | Laparoscope, Gynecologic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2017-07-21 |
| Record revised | 2024-11-21 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature -20 to 60 °C |
| Sizes | Outer diameter 2.1 to 20 mm; length 55 to 400 mm |
| Distribution end date | 2026-02-06 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8309121 | Length 82 mm | In distribution | |
| 8754201 | Length 250 mm | In distribution | |
| 8754202 | Outer Diameter 2.3 mm | In distribution | |
| 830212 | Length 120 mm | In distribution | |
| 830215 | Length 150 mm | In distribution | |
| 8383611 | Length 320 mm | In distribution | |
| 83071125 | 10 | In distribution | |
| 83075021 | Outer Diameter 20 mm | In distribution | |
| 83075011 | In distribution | ||
| 8754211 | Outer Diameter 2.3 mm | In distribution | |
| 8754212 | Length 164 mm | In distribution | |
| 830208 | Outer Diameter 2.1 mm | In distribution | |
| 23070015 | Withdrawn | ||
| 8921131 | Withdrawn | ||
| 83932419 | Outer Diameter 5 mm | Withdrawn | |
| 83075022 | Outer Diameter 20 mm | 10 | Withdrawn |
| 83070111 | Withdrawn | ||
| 83070115 | 10 | Withdrawn | |
| 8923131 | Withdrawn | ||
| 8307502 | 10 | Withdrawn | |
| 83952147 | Outer Diameter 10 mm | Withdrawn | |
| 8924133 | Withdrawn | ||
| 8307503 | 10 | Withdrawn | |
| 8386211 | Outer Diameter 15 mm | Withdrawn | |
| 23070012 | Withdrawn | ||
| 8385181 | Outer Diameter 10 mm | Withdrawn | |
| 409001203 | Withdrawn | ||
| 83071203 | Outer Diameter 20 mm | 10 | Withdrawn |
| 837026 | Length 350 mm | Withdrawn | |
| 83071205 | Outer Diameter 20 mm | 10 | Withdrawn |
| 83071123 | 10 | Withdrawn | |
| 835114 | Outer Diameter 5.5 mm | Withdrawn | |
| 8921133 | Withdrawn | ||
| 83952447 | Outer Diameter 10 mm | Withdrawn | |
| 8309012 | Length 55 mm | Withdrawn | |
| 8923133 | Withdrawn | ||
| 23070020 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoplus | Endoplus | 448 |
| Integra® MicroFrance® | Integra Microfrance SAS | 273 |
| Symmetry Surgical® | Aspen Surgical Products, Inc. | 139 |
| Laparoscope, Gynecologic (And Accessories) | Karl Storz GmbH & Co. KG | 119 |
| Elmed | Elmed, Inc. | 96 |
| Olympus | Olympus Winter & IBE Gmbh | 71 |
| Core Dynamics | ConMed Corporation | 52 |
| Symmetry | Aspen Surgical Products, Inc. | 48 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 45 |
| Take-Apart | Karl Storz GmbH & Co. KG | 31 |
| Blueendo | Trokamed Gmbh | 28 |
| Olmypus | Olympus Winter & IBE Gmbh | 23 |
Showing 12 of 396. All products under Laparoscope, Gynecologic (And Accessories)
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.