Marina Medical
Pessary Fitting Set, 6 Sequentially Sized Pessaries Same Style
4manufacturers in China registered for this device type
144catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
All of them in Guangdong. 3 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 |
| B&A Precision Silicone Rubber (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Guangzhou Fame Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 1 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Marina Medical Instruments, Inc., United States |
|---|---|
| FDA product code | HHW |
| Device type | Pessary, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3575 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-01-16 |
| Record revised | 2025-03-10 (version 4) |
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 18 to 35.5 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BSH3.50 | In distribution | |
| BR1.75S | In distribution | |
| BM3.75S | In distribution | |
| BHD65S | In distribution | |
| BHD90 | In distribution | |
| BCU41 | In distribution | |
| BCU29 | In distribution | |
| BID2.25 | In distribution | |
| BDSH80 | In distribution | |
| BG1.50D | In distribution | |
| BR2.75S | In distribution | |
| BM2.75S | In distribution | |
| BR3.50 | In distribution | |
| BSH3.25 | In distribution | |
| BRK2.00S | In distribution | |
| BCU45 | In distribution | |
| BCU56D | In distribution | |
| BRK2.25S | In distribution | |
| BD2.75 | In distribution | |
| BR2.25 | Length 30.5 cm | In distribution |
| BSH2.75 | In distribution | |
| BHD95S | In distribution | |
| BG2.25D | In distribution | |
| BM3.00 | In distribution | |
| BR2.50S | Length 35.5 cm | In distribution |
| BRK2.75 | In distribution | |
| BD2.00 | In distribution | |
| BSH1.50 | In distribution | |
| BSH2.50 | In distribution | |
| BM2.50 | In distribution | |
| BRK3.50S | In distribution | |
| BFS4000 | In distribution | |
| BRK2.00 | Length 25.5 cm | In distribution |
| BRK2.50S | In distribution | |
| BSH1.50 | In distribution | |
| BRK2.75S | In distribution | |
| BHD80S | In distribution | |
| BFS1000-A | In distribution | |
| BOV3.50S | In distribution | |
| BHD80 | In distribution | |
| BGS3.00D | In distribution | |
| BOV3.75S | In distribution | |
| BG1.75D | In distribution | |
| BRK4.00S | In distribution | |
| BR1.75 | In distribution | |
| BRK3.00S | In distribution | |
| BCU33D | In distribution | |
| BSH3.00 | In distribution | |
| BR2.00S | Length 18 cm | In distribution |
| BFS3000 | In distribution | |
| BG2.00D | In distribution | |
| BHD65 | In distribution | |
| BHD100S | In distribution | |
| BCU29DP | In distribution | |
| BHD75S | In distribution | |
| BHD75 | In distribution | |
| BCU56 | In distribution | |
| BDSH50 | In distribution | |
| BDSH80S | In distribution | |
| BRK3.50 | In distribution | |
| BDSH85 | In distribution | |
| BFS5000 | In distribution | |
| BM2.25S | In distribution | |
| BM3.50S | In distribution | |
| BR3.50S | In distribution | |
| BR3.75 | Length 25.5 cm | In distribution |
| BRK3.75 | In distribution | |
| BR4.00S | In distribution | |
| BCU29D | In distribution | |
| BSH2.25 | In distribution | |
| BRK1.75 | In distribution | |
| BM3.50 | In distribution | |
| BOV2.75S | In distribution | |
| BDSH75S | In distribution | |
| BHD85S | In distribution | |
| BRK1.75S | In distribution | |
| BM2.25 | In distribution | |
| BD2.25 | In distribution | |
| BM3.00S | In distribution | |
| BD3.25 | In distribution | |
| BID2.75 | In distribution | |
| BHD70S | In distribution | |
| BR3.75S | In distribution | |
| BRK3.25S | In distribution | |
| BD2.50 | In distribution | |
| BOV2.00S | In distribution | |
| BCU50 | In distribution | |
| BHD95 | In distribution | |
| BDSH85S | In distribution | |
| BSH1.75 | In distribution | |
| BCU45D | In distribution | |
| BRK3.00 | In distribution | |
| BR3.00S | In distribution | |
| BCU75D | In distribution | |
| BD3.75 | In distribution | |
| BDSH50S | In distribution | |
| BHD70 | In distribution | |
| BCU75 | In distribution | |
| BHD110S | In distribution | |
| BD3.00 | In distribution | |
| BCU37 | In distribution | |
| BCU63D | In distribution | |
| BR4.00 | In distribution | |
| BCU25D | In distribution | |
| BCU25 | In distribution | |
| BOV2.25S | In distribution | |
| BR2.50 | In distribution | |
| BR2.25S | In distribution | |
| BR2.00 | Length 20 cm | In distribution |
| BFS6000 | In distribution | |
| BCU37D | In distribution | |
| BHD90S | In distribution | |
| BGS3.25D | In distribution | |
| BOV3.00S | In distribution | |
| BM3.25 | In distribution | |
| BR3.25 | In distribution | |
| BGS3.50D | In distribution | |
| BR3.25S | In distribution | |
| BCU50D | In distribution | |
| BR2.75 | In distribution | |
| BR3.00 | In distribution | |
| BM3.75 | In distribution | |
| BHD110 | In distribution | |
| BRK.375S | In distribution | |
| BCU70 | In distribution | |
| BOV3.00 | In distribution | |
| BM3.25S | In distribution | |
| BRK3.25 | In distribution | |
| BCU33 | In distribution | |
| BOV2.50S | In distribution | |
| BHD85 | In distribution | |
| BM2.50S | In distribution | |
| BRK2.50 | In distribution | |
| BOV4.00S | In distribution | |
| BD3.50 | In distribution | |
| BOV3.25S | In distribution | |
| BRK2.25 | In distribution | |
| BID2.50 | In distribution | |
| BFS1000 | In distribution | |
| BHD105 | In distribution | |
| BCU63 | In distribution | |
| BCU41D | In distribution | |
| BSH2.00 | In distribution | |
| BCU70D | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pessary, Vaginal | Panpac Medical Corporation | 628 |
| Milex | Coopersurgical, Inc. | 592 |
| Bioteque America, Inc. | Bioteque America, Inc. | 221 |
| Bioteque | Bioteque Taiwan Ltd. | 209 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 189 |
| HNM Women Care | HNM Stainless, LLC. | 187 |
| Medline | Medline Industries, Inc. | 162 |
| EvaCare | Personal Medical Corp. | 128 |
| Hayden Medical | Hayden Medical Inc | 81 |
| Premier | Premier Dental Products Co. | 58 |
| LTL Medical | Bioteque Taiwan Ltd. | 56 |
| Sklar® | Sklar Corporation | 37 |
Showing 12 of 180. All products under Pessary, Vaginal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K031463 | 2003-11-18 |
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.