Marina Medical
4.5 Uterine Manipulator/Injector, 10cc Balloon, Sterile/ Disposable, 12/BX-ACTIVE
5manufacturers in China registered for this device type
29catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (2), Beijing (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Tonglu Qianyan Medtech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Beijing Hangtian Kadi Technology R&D Institute | Beijing | Beijing | Manufacturer | 5 |
Record
| Listed by | Marina Medical Instruments, Inc., United States |
|---|---|
| FDA product code | LKF |
| Device type | Cannula, Manipulator/Injector, Uterine |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-06 |
| Record revised | 2025-01-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number |
| Sizes | Length 4.5 to 30.5 cm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 340-203M | Length 30.5 cm | In distribution | |
| 340-235 | In distribution | ||
| 800-342 | In distribution | ||
| 338-100 | Length 25.5 cm | In distribution | |
| 338-300 | Length 25.5 cm | In distribution | |
| 340-224 | Length 4.5 cm | In distribution | |
| 340-203 | Length 30.5 cm | In distribution | |
| MM1-610 | In distribution | ||
| 800-344 | In distribution | ||
| 338-301 | In distribution | ||
| 340-209 | Length 28.5 cm | In distribution | |
| 800-351 | In distribution | ||
| 338-526 | In distribution | ||
| 800-395D | In distribution | ||
| 800-817 | Length 20 cm | In distribution | |
| 340-234 | In distribution | ||
| 800-909 | In distribution | ||
| 340-213 | Length 4.5 cm | In distribution | |
| 800-816 | Length 30 cm | In distribution | |
| R57420A | In distribution | ||
| 340-230 | In distribution | ||
| AMI-1151 | 12 | In distribution | |
| 800-341 | In distribution | ||
| 800-814 | Length 23 cm | In distribution | |
| 340-223 | Length 5 cm | In distribution | |
| MM1-610 | In distribution | ||
| 800-350S | In distribution | ||
| AMI-6003 | 12 | In distribution | |
| 800-815 | Length 10 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Elmed | Elmed, Inc. | 39 |
| Cannula, Manipulator/Injector, Uterine | C R I | 31 |
| HSG Catheter | Titus Medical LLC | 26 |
| HNM Women Care | HNM Stainless, LLC. | 20 |
| Bioteque | Bioteque Taiwan Ltd. | 16 |
| Viky | Endocontrol | 15 |
| Cannula, Manipulator/Injector, Uterine | Panpac Medical Corporation | 14 |
| Uterine ElevatOR Pro | THE O R Company PTY Ltd | 12 |
| Valtchev Uterine Mobilizer | Conkin Surgical Instruments Ltd. | 10 |
| Novo Surgical | Novo Surgical, Inc. | 9 |
| McCarus-Volker Fornisee® System | LSI Solutions Inc. | 9 |
| Cook | Cook Incorporated | 8 |
Showing 12 of 111. All products under Cannula, Manipulator/Injector, Uterine
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K010296 | 2001-04-11 |
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.