Marina Medical

Lateral Vaginal Retractor, NonConductive, Closed Shanks, 2.5in Blades

Registry build 21.09.26
8manufacturers in China registered for this device type
19catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (2), Shanghai (2), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code HDL
Manufacturer City Province Registered as Device types
Forefront (Xiamen) Medical Devices Co., Ltd. Xiamen Fujian Contract manufacturer 8
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Xinhua Surgical Instrument Co., Ltd. Zibo Shandong Manufacturer 222
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Zhejiang Gongdong Medical Technology Co., Ltd. Taizhou Zhejiang Contract manufacturer 40
Shanghai Wilpower Industrial Co., Ltd. Shanghai Shanghai Exporter 33

Record

Regulatory record for Marina Medical
Listed by Marina Medical Instruments, Inc., United States
FDA product code HDL
Device type Retractor, Vaginal
Device class Class 1
Regulation 21 CFR 884.4520
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2022-11-07
Record revised 2025-01-17 (version 3)

Specifications

Specifications
MRI safety MR Safe
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Marina Medical
Catalogue number Size Status
254-519 In distribution
310-611 In distribution
254-414 In distribution
254-412 In distribution
254-410 In distribution
254-417 In distribution
250-612 In distribution
254-514 In distribution
254-615 In distribution
254-613 In distribution
310-612 In distribution
337-196 In distribution
254-407 In distribution
254-518 In distribution
254-415 In distribution
254-513 In distribution
254-620 In distribution
254-516 In distribution
254-512 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Sklar® Sklar Corporation 72
Ambler Surgical Ambler Surgical, LLC 60
Novo Surgical Novo Surgical, Inc. 52
HNM Medical HNM Stainless, LLC. 52
Elmed Incorporated Elmed, Inc. 48
Millennium Avalign Technologies, Inc. 47
Novo Surgical Inc. Novo Surgical, Inc. 43
Aesculap Aesculap AG 38
Surgical Direct Surgical Direct, Inc. 27
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 25
Pilling Teleflex Medical LLC 25
V. Mueller Steris Corporation 22

Showing 12 of 59. All products under Retractor, Vaginal

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer