Hayden Medical
Gellhorn Pessary Fitting Kit, #2-7 with regular stem, includes case
4manufacturers in China registered for this device type
81catalogue numbers in this listing
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 | Hayden Medical Inc, United States |
|---|---|
| FDA product code | HHW |
| Device type | Pessary, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3575 |
| Establishment | Repacker / relabeller |
| 510(k) | K092981 |
| Record published | 2022-08-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PCU41D | In distribution | |
| PD3.25 | In distribution | |
| PR2.50 | In distribution | |
| PD3.50 | In distribution | |
| PR3.25 | In distribution | |
| PRK3.00 | In distribution | |
| PR3.00S | In distribution | |
| PRK3.50S | In distribution | |
| POV2.00S | In distribution | |
| PGS3.25D | In distribution | |
| POV2.75S | In distribution | |
| POV2.25 | In distribution | |
| PR4.00S | In distribution | |
| PRK2.00 | In distribution | |
| PRK3.50 | In distribution | |
| PRK2.25 | In distribution | |
| PCU33D | In distribution | |
| PG3.00D | In distribution | |
| PG1.50D | In distribution | |
| PDSH75S | In distribution | |
| PR2.00 | In distribution | |
| PG1.75D | In distribution | |
| PD2.00 | In distribution | |
| PD3.75 | In distribution | |
| POV3.50S | In distribution | |
| PGS2.50D | In distribution | |
| PD3.00 | In distribution | |
| PR2.50S | In distribution | |
| PCU50D | In distribution | |
| PGS2.75D | In distribution | |
| PRK3.00S | In distribution | |
| PGH75S | In distribution | |
| PRK3.25S | In distribution | |
| PDSH70S | In distribution | |
| PGS2.00D | In distribution | |
| PR3.00 | In distribution | |
| PRK2.75S | In distribution | |
| PG2.00D | In distribution | |
| PR2.25S | In distribution | |
| PGH70S | In distribution | |
| PRK2.25S | In distribution | |
| PRK3.25 | In distribution | |
| PGS1.75D | In distribution | |
| PR2.75 | In distribution | |
| POV3.00 | In distribution | |
| PG2.50D | In distribution | |
| POV2.25S | In distribution | |
| PRK2.50 | In distribution | |
| PD2.75 | In distribution | |
| PD2.50 | In distribution | |
| PRK2.75 | In distribution | |
| PG3.25D | In distribution | |
| PDSH65S | In distribution | |
| POV2.50S | In distribution | |
| PR2.75S | In distribution | |
| PCU56D | In distribution | |
| PDSH60S | In distribution | |
| PG2.25D | In distribution | |
| PGS2.25D | In distribution | |
| PGS3.00D | In distribution | |
| PCU45D | In distribution | |
| PFS5000 | In distribution | |
| PR2.25 | In distribution | |
| PCU25D | In distribution | |
| PR2.00S | In distribution | |
| PR3.25S | In distribution | |
| PRK2.00S | In distribution | |
| POV2.75 | In distribution | |
| PRK2.50S | In distribution | |
| PGH80S | In distribution | |
| POV3.00S | In distribution | |
| POV2.00 | In distribution | |
| PG2.75D | In distribution | |
| PR3.75S | In distribution | |
| PCU37D | In distribution | |
| POV2.50 | In distribution | |
| PR3.50S | In distribution | |
| POV3.25S | In distribution | |
| PD2.25 | In distribution | |
| PGH65S | In distribution | |
| PCU29D | 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 |
| EvaCare | Personal Medical Corp. | 128 |
| 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.