Premier
Cube Pessary W/O Drainage Holes #10
4manufacturers in China registered for this device type
58catalogue 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 | Premier Dental Products Co., 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) | K031463 |
| Record published | 2016-09-16 |
| Record revised | 2019-11-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1040414 | In distribution | |
| 1040103 | In distribution | |
| 1040205 | In distribution | |
| 1010111 | In distribution | |
| 1040202 | In distribution | |
| 1040407 | In distribution | |
| 1040114 | In distribution | |
| 1040107 | In distribution | |
| 1040104 | In distribution | |
| 1040418 | In distribution | |
| 1040102 | In distribution | |
| 1040409 | In distribution | |
| 1040417 | In distribution | |
| 1040410 | In distribution | |
| 1040305 | In distribution | |
| 1040207 | In distribution | |
| 1040406 | In distribution | |
| 1040106 | In distribution | |
| 1040404 | In distribution | |
| 1040600 | In distribution | |
| 1040402 | In distribution | |
| 1040303 | In distribution | |
| 1040113 | In distribution | |
| 1040116 | In distribution | |
| 1040208 | In distribution | |
| 1040101 | In distribution | |
| 1040420 | In distribution | |
| 1040119 | In distribution | |
| 1040302 | In distribution | |
| 1040405 | In distribution | |
| 1040401 | In distribution | |
| 1040306 | In distribution | |
| 1040115 | In distribution | |
| 1040204 | In distribution | |
| 1040419 | In distribution | |
| 1040412 | In distribution | |
| 1040411 | In distribution | |
| 1040416 | In distribution | |
| 1040304 | In distribution | |
| 1040108 | In distribution | |
| 1040413 | In distribution | |
| 1040118 | In distribution | |
| 1040109 | In distribution | |
| 1040408 | In distribution | |
| 1040111 | In distribution | |
| 1040200 | In distribution | |
| 1040203 | In distribution | |
| 1040421 | In distribution | |
| 1040300 | In distribution | |
| 1040415 | In distribution | |
| 1040400 | In distribution | |
| 1040301 | In distribution | |
| 1040403 | In distribution | |
| 1040112 | In distribution | |
| 1040105 | In distribution | |
| 1040201 | In distribution | |
| 1040117 | In distribution | |
| 1040206 | 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 |
| Hayden Medical | Hayden Medical Inc | 81 |
| 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.