Pessary, Vaginal
Panpac’s pessaries are indicated for use as removable structures placed in the vagina to support the pelvic organs. Pessary use is contraindicated in cases of acute genital tract…
Panpac’s pessaries are indicated for use as removable structures placed in the vagina to support the pelvic organs. Pessary use is contraindicated in cases of acute genital tract inflections, pelvic inflections, or non-compliant patients.
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 | Panpac Medical Corporation, Taiwan |
|---|---|
| FDA product code | HHW |
| Device type | Pessary, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3575 |
| 510(k) | K161106 |
| Record published | 2016-08-18 |
| Record revised | 2022-11-07 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10 |
| Distribution end date | 2016-08-18 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Gd9-W | In distribution | |
| DSH1-W | In distribution | |
| CUd1 | In distribution | |
| GS7 | In distribution | |
| DSHs3 | In distribution | |
| Gd0-W | In distribution | |
| RK3-W | In distribution | |
| RKs6-W | In distribution | |
| M6-P | In distribution | |
| D1-P | In distribution | |
| M3-W | In distribution | |
| GS6 | In distribution | |
| Gd1 | In distribution | |
| RKs2-P | In distribution | |
| R1-P | In distribution | |
| CUd3 | In distribution | |
| Rs0-P | In distribution | |
| HDs8-W | In distribution | |
| IR4 | In distribution | |
| RK5-P | In distribution | |
| RK0-W | In distribution | |
| GS4-P | In distribution | |
| CUd2-W | In distribution | |
| CU2-P | In distribution | |
| Rs8-P | In distribution | |
| CP6 | In distribution | |
| DSHs3-W | In distribution | |
| HDs7-W | In distribution | |
| FS6000 | In distribution | |
| CPs6-W | In distribution | |
| HDs6-W | In distribution | |
| SH6-W | In distribution | |
| DSHs6-P | In distribution | |
| RKs4 | In distribution | |
| GS9-P | In distribution | |
| M4-P | In distribution | |
| GH4 | In distribution | |
| RK5 | In distribution | |
| DSHs2 | In distribution | |
| CUd8-W | In distribution | |
| RKs3-P | In distribution | |
| CPs2 | In distribution | |
| D4 | In distribution | |
| KC09 | In distribution | |
| HD9-P | In distribution | |
| OV7-P | In distribution | |
| ID5 | In distribution | |
| D7 | In distribution | |
| Ms7-W | In distribution | |
| Rs5-W | In distribution | |
| D2 | In distribution | |
| CPs6 | In distribution | |
| GS0 | In distribution | |
| FS9000 | In distribution | |
| CU4-P | In distribution | |
| CU4 | In distribution | |
| SH8 | In distribution | |
| CU2-W | In distribution | |
| CP3-P | In distribution | |
| CUd7-P | In distribution | |
| Ms5 | In distribution | |
| RK0-P | In distribution | |
| R7-P | In distribution | |
| Gd3 | In distribution | |
| SH3 | In distribution | |
| HDs0 | In distribution | |
| Gd9-P | In distribution | |
| RKs7-W | In distribution | |
| RK4-P | In distribution | |
| CU4-W | In distribution | |
| DSHs3-P | In distribution | |
| R8 | In distribution | |
| M6-W | In distribution | |
| HDs2 | In distribution | |
| GH5-P | In distribution | |
| HD6-P | In distribution | |
| OVs1-P | In distribution | |
| D3-P | In distribution | |
| M7-P | In distribution | |
| OV7-W | In distribution | |
| SH5-W | In distribution | |
| OV3-P | In distribution | |
| R2 | In distribution | |
| RKs5 | In distribution | |
| CPs3-W | In distribution | |
| R8-W | In distribution | |
| CU6-W | In distribution | |
| CUd8 | In distribution | |
| M2-P | In distribution | |
| OV9-W | In distribution | |
| Rs6 | In distribution | |
| FSP10 | In distribution | |
| DSHs0-P | In distribution | |
| FS5000 | In distribution | |
| Ms3-W | In distribution | |
| OV2-W | In distribution | |
| RKs6-P | In distribution | |
| GS1 | In distribution | |
| RKs3 | In distribution | |
| GS3 | In distribution | |
| CPs0 | In distribution | |
| Rs4-P | In distribution | |
| HD6-W | In distribution | |
| R6-W | In distribution | |
| OV1-W | In distribution | |
| HDs9 | In distribution | |
| Rs1-P | In distribution | |
| CUd9-W | In distribution | |
| SH8-W | In distribution | |
| HD0-W | In distribution | |
| CUd4-W | In distribution | |
| Gd4 | In distribution | |
| HD0-P | In distribution | |
| CU8 | In distribution | |
| RKs2 | In distribution | |
| OVs4-P | In distribution | |
| HD5-W | In distribution | |
| Rs5 | In distribution | |
| OVs5-P | In distribution | |
| CU7 | In distribution | |
| RKs4-P | In distribution | |
| RK5-W | In distribution | |
| OVs9-W | In distribution | |
| HD4 | In distribution | |
| KC04 | In distribution | |
| HDs3-W | In distribution | |
| GS5 | In distribution | |
| FS1000 | In distribution | |
| RK7-P | In distribution | |
| Rs8-W | In distribution | |
| Ms8-W | In distribution | |
| DSHs7-P | In distribution | |
| GH6 | In distribution | |
| DISP-R3 | In distribution | |
| DSHs6 | In distribution | |
| D3-W | In distribution | |
| CP0 | In distribution | |
| Ms7 | In distribution | |
| R5 | In distribution | |
| IR6 | In distribution | |
| CU5 | In distribution | |
| DSH6 | In distribution | |
| CPs5-W | In distribution | |
| CP4-P | In distribution | |
| Gd0 | In distribution | |
| RK7-W | In distribution | |
| FS3000 | In distribution | |
| OVs2-W | In distribution | |
| DSH7-P | In distribution | |
| RKs2-W | In distribution | |
| Rs1-W | In distribution | |
| HD1-W | In distribution | |
| DSHs0 | In distribution | |
| FSP12 | In distribution | |
| D5-P | In distribution | |
| HD7-W | In distribution | |
| IR1 | In distribution | |
| GH3 | In distribution | |
| M4 | In distribution | |
| RK6-P | In distribution | |
| GH2 | In distribution | |
| CUd5 | In distribution | |
| DSHs1-P | In distribution | |
| DSH4-W | In distribution | |
| OV1 | In distribution | |
| CU0-P | In distribution | |
| M5 | In distribution | |
| CUd7-W | In distribution | |
| OV9 | In distribution | |
| OV3 | In distribution | |
| HD1-P | In distribution | |
| OVs1 | In distribution | |
| OVs6-P | In distribution | |
| GS6-W | In distribution | |
| DSH5 | In distribution | |
| CUd10-W | In distribution | |
| CP0-P | In distribution | |
| CPs3 | In distribution | |
| R3-P | In distribution | |
| OVs3-P | In distribution | |
| CPs4-W | In distribution | |
| M2-W | In distribution | |
| KC12 | In distribution | |
| R9-W | In distribution | |
| Gd4-W | In distribution | |
| DSHs6-W | In distribution | |
| CPs1-P | In distribution | |
| GH4-P | In distribution | |
| OVs2-P | In distribution | |
| D0-W | In distribution | |
| SH7-W | In distribution | |
| OVs4 | In distribution | |
| Rs7 | In distribution | |
| Gd3-P | In distribution | |
| R1-W | In distribution | |
| M2 | In distribution | |
| CUd4 | In distribution | |
| CU9-P | In distribution | |
| KC08 | In distribution | |
| HDs0-W | In distribution | |
| FS8000 | In distribution | |
| DSH5-W | In distribution | |
| SH9-W | In distribution | |
| OVs5 | In distribution | |
| OV5-W | In distribution | |
| CP0-W | In distribution | |
| HD8-W | In distribution | |
| OV4-W | In distribution | |
| GH2-P | In distribution | |
| D6 | In distribution | |
| GH1-P | In distribution | |
| HDs4 | In distribution | |
| DSH2-P | In distribution | |
| OV6-W | In distribution | |
| HD3-P | In distribution | |
| DSHs4 | In distribution | |
| OV8-P | In distribution | |
| ID4 | In distribution | |
| Ms4-W | In distribution | |
| GS7-P | In distribution | |
| Rs8 | In distribution | |
| Gd6-W | In distribution | |
| IR9 | In distribution | |
| DSH6-P | In distribution | |
| D5-W | In distribution | |
| Rs3-W | In distribution | |
| GS9-W | In distribution | |
| CUd6-P | In distribution | |
| GSR1 | In distribution | |
| DSH0 | In distribution | |
| ID3 | In distribution | |
| RK4 | In distribution | |
| GS0-P | In distribution | |
| D6-P | In distribution | |
| M4-W | In distribution | |
| DISP-R7 | In distribution | |
| RK3-P | In distribution | |
| CUd7 | In distribution | |
| RKs5-W | In distribution | |
| D7-W | In distribution | |
| FS1100 | In distribution | |
| SH9 | In distribution | |
| FSP08 | In distribution | |
| HDs0-P | In distribution | |
| Ms4-P | In distribution | |
| GS3-P | In distribution | |
| DSH1 | In distribution | |
| Gd1-W | In distribution | |
| CP7 | In distribution | |
| Rs2 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K173351 | 2018-10-31 |
| K153422 | 2016-07-14 |
| K132670 | 2014-06-04 |
| K092981 | 2010-07-22 |
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.