EvaCare
#7 Cube Pessary 56mm The EvaCare cube pessary without drains is constructed of medical grade silicone, has more suction than a with drains version, and is indicated for a second or…
#7 Cube Pessary 56mm The EvaCare cube pessary without drains is constructed of medical grade silicone, has more suction than a with drains version, and is indicated for a second or third-degree prolapse, including procidentia, as well as cystocele and rectocele.
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 | Personal Medical Corp., United States |
|---|---|
| FDA product code | HHW |
| Device type | Pessary, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3575 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K993308 |
| Record published | 2026-07-14 |
| Record revised | 2026-07-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Width 25 to 98 mm; length 50 to 80 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DSH65 #3 | Length 65 mm | In distribution |
| D2.25 #1 | Width 55 mm | In distribution |
| R2.00S #1 | Width 51 mm | In distribution |
| DSH55 #1 | Length 55 mm | In distribution |
| RK2.50S #3 | Width 61 mm | In distribution |
| G275SHD #5 | Width 70 mm | In distribution |
| R2.80 #4.5 | Width 70 mm | In distribution |
| svR300S | Width 76 mm | In distribution |
| CP60 #2 | Width 58 mm | In distribution |
| D3.00 #4 | Width 74 mm | In distribution |
| G200D #2 | Width 51 mm | In distribution |
| CU50 #6 | Width 50 mm | In distribution |
| CP65S #3 | Width 62 mm | In distribution |
| R2.75 #4 | Width 67 mm | In distribution |
| CP60S #2 | Width 58 mm | In distribution |
| svR325S | Width 83 mm | In distribution |
| CP50S #0 | Width 50 mm | In distribution |
| DSH75S #5 | Length 75 mm | In distribution |
| RK2.75S #4 | Width 68 mm | In distribution |
| R2.75S #4 | Width 67 mm | In distribution |
| CP75 #5 | Width 75 mm | In distribution |
| R3.50S #7 | Width 86 mm | In distribution |
| SH2.50 #4 | Width 64 mm | In distribution |
| SH1.50 #0 | Width 38 mm | In distribution |
| G175SHD #1 | Width 45 mm | In distribution |
| CU25D #0 | Width 25 mm | In distribution |
| CU25 #0 | Width 25 mm | In distribution |
| CU37D #3 | Width 37 mm | In distribution |
| CU41 #4 | Width 41 mm | In distribution |
| DSH55S #1 | Length 55 mm | In distribution |
| R2.25S #2 | Width 57 mm | In distribution |
| CU56 #7 | Width 56 mm | In distribution |
| D2.50 #2 | Width 64 mm | In distribution |
| CU37 #3 | Width 37 mm | In distribution |
| CP65 #3 | Width 63 mm | In distribution |
| R3.75S #8 | Width 94 mm | In distribution |
| G150SHD #0 | Width 42 mm | In distribution |
| D2.00 #0 | Width 50 mm | In distribution |
| DSH60 #2 | Length 60 mm | In distribution |
| G250SHD #4 | Width 64 mm | In distribution |
| CU29 #1 | Width 29 mm | In distribution |
| SH3.00 #6 | Width 76 mm | In distribution |
| SH2.75 #5 | Width 70 mm | In distribution |
| SH3.50 #8 | Width 87 mm | In distribution |
| RK3.25S #6 | Width 81 mm | In distribution |
| RK3.50S #7 | Width 87 mm | In distribution |
| DSH85 #7 | Width 85 mm | In distribution |
| G350D #8 | Width 89 mm | In distribution |
| G250D #4 | Width 63 mm | In distribution |
| DSH85S #7 | Width 85 mm | In distribution |
| RK2.50 #3 | Width 61 mm | In distribution |
| RK2.75 #4 | Width 68 mm | In distribution |
| D3.50 #6 | Width 87 mm | In distribution |
| DSH50S #0 | Length 50 mm | In distribution |
| R3.25S #6 | Width 80 mm | In distribution |
| R2.00 #1 | Width 51 mm | In distribution |
| R1.75S #0 | In distribution | |
| DSH80 #6 | Length 80 mm | In distribution |
| G175D #1 | Width 45 mm | In distribution |
| G375D #9 | Width 95 mm | In distribution |
| CU29D #1 | Width 29 mm | In distribution |
| DSH65S #3 | Length 65 mm | In distribution |
| G350SHD #8 | Width 89 mm | In distribution |
| RK2.00 #1 | Width 48 mm | In distribution |
| G200SHD #2 | Width 51 mm | In distribution |
| DSH80S #6 | Length 80 mm | In distribution |
| DSH70S #4 | Length 70 mm | In distribution |
| RK3.50 #7 | Width 87 mm | In distribution |
| R4.00 #9 | In distribution | |
| D2.75 #3 | Width 68 mm | In distribution |
| CU41D #4 | Width 41 mm | In distribution |
| D3.75 #7 | Width 93 mm | In distribution |
| R2.50S #3 | Width 62 mm | In distribution |
| CP70 #4 | Width 68 mm | In distribution |
| RK3.25 #6 | Width 81 mm | In distribution |
| R2.60 #3.5 | Width 64.5 mm | In distribution |
| RK1.75S #0 | Width 43 mm | In distribution |
| G325D #7 | Width 83 mm | In distribution |
| R4.00S #9 | Width 98 mm | In distribution |
| R2.50 #3 | Width 62 mm | In distribution |
| svR275S | Width 70 mm | In distribution |
| R2.25 #2 | Width 55 mm | In distribution |
| RK2.00S #1 | Width 48 mm | In distribution |
| DSH50 #0 | Length 50 mm | In distribution |
| CU33D #2 | Width 33 mm | In distribution |
| CP55S#1 | Width 54 mm | In distribution |
| CP85S #7 | Width 85 mm | In distribution |
| CP80 #6 | Width 79 mm | In distribution |
| CP75S #5 | Width 74 mm | In distribution |
| CU56D #7 | Width 56 mm | In distribution |
| CU33 #2 | Width 33 mm | In distribution |
| R3.50 #7 | Width 86 mm | In distribution |
| DSH70 #4 | Length 70 mm | In distribution |
| CU45D #5 | Width 45 mm | In distribution |
| R3.00 #5 | Width 74 mm | In distribution |
| CU45 #5 | Width 45 mm | In distribution |
| G300SHD #6 | Width 76 mm | In distribution |
| RK3.00S #5 | Width 74 mm | In distribution |
| svR350S | Width 89 mm | In distribution |
| SH3.25 #7 | Width 81 mm | In distribution |
| G275D #5 | Width 70 mm | In distribution |
| CP80S #6 | Width 79 mm | In distribution |
| R3.00S #5 | Width 74 mm | In distribution |
| R2.25S #2 | Width 55 mm | In distribution |
| R1.75 #0 | Width 43 mm | In distribution |
| G375SHD #9 | Width 95 mm | In distribution |
| G325SHD #7 | Width 83 mm | In distribution |
| D3.25 #5 | Width 81 mm | In distribution |
| G300D #6 | Width 76 mm | In distribution |
| SH2.00 #2 | Width 51 mm | In distribution |
| svR250S | Width 64 mm | In distribution |
| CP85 #7 | Width 85 mm | In distribution |
| SH1.75 #1 | Width 45 mm | In distribution |
| RK1.75 #0 | Width 43 mm | In distribution |
| CP55 #1 | Width 55 mm | In distribution |
| G225D #3 | Width 57 mm | In distribution |
| DSH75 #5 | Length 75 mm | In distribution |
| RK3.00 #5 | Width 74 mm | In distribution |
| RK2.25 #2 | Width 56 mm | In distribution |
| RK2.25S #2 | Width 56 mm | In distribution |
| CU50D #6 | Width 50 mm | In distribution |
| G150D #0 | Width 42 mm | In distribution |
| SH2.25 #3 | Width 57 mm | In distribution |
| CP50 #0 | Width 50 mm | In distribution |
| DSH60S #2 | Length 57 mm | In distribution |
| CP70S #4 | In distribution | |
| G225SHD #3 | Width 57 mm | In distribution |
| R3.75 #8 | Width 94 mm | 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 |
| Marina Medical | Marina Medical Instruments, Inc. | 144 |
| 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
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.