Blueendo
Cutting Module Ø 15 mm to be used with 02-33103, Color Code grey, for Morcellator System, single use, sterile, 5 pcs./ box
7manufacturers in China registered for this device type
28catalogue numbers in this listing
1510(k) clearance
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 | Trokamed Gmbh, Germany |
|---|---|
| FDA product code | HET |
| Device type | Laparoscope, Gynecologic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Establishment | Contract manufacturer, Manufacturer |
| Record published | 2021-05-10 |
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 |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02-33045 | In distribution | |
| 55-152005 | In distribution | |
| 55-122005 | In distribution | |
| 55-121006 | In distribution | |
| 02-33039US | In distribution | |
| 55-151001 | In distribution | |
| 55-000321-V2 | In distribution | |
| 55-201006 | In distribution | |
| 55-121001 | In distribution | |
| 55-000031-V2 | In distribution | |
| 55-152006 | In distribution | |
| 02-33049 | In distribution | |
| 53-000032 | In distribution | |
| 02-33117 | In distribution | |
| 53-001020 | In distribution | |
| 55-201001 | In distribution | |
| 55-152001 | In distribution | |
| 02-33076 | In distribution | |
| 02-33103 | In distribution | |
| 02-33041 | In distribution | |
| 02-33008 | In distribution | |
| 02-33106 | In distribution | |
| 55-202005 | In distribution | |
| 55-151006 | In distribution | |
| 53-000012 | In distribution | |
| 55-000051 | In distribution | |
| 53-001015 | In distribution | |
| 02-33109 | In distribution |
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 |
| Laparoscope, Gynecologic (And Accessories) | Richard Wolf Gmbh | 37 |
| Take-Apart | Karl Storz GmbH & Co. KG | 31 |
| Olmypus | Olympus Winter & IBE Gmbh | 23 |
Showing 12 of 396. All products under Laparoscope, Gynecologic (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091010 | 2011-03-01 |
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.