Sklar®
Silicone VAG Dilator SET/4 MED
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong Yuxiang Silicone & Plastic Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 2 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | HDX |
| Device type | Dilator, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3900 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K003380 |
| Record published | 2017-06-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 90-5262 | 4 | In distribution | |
| 90-5264 | 4 | In distribution | |
| 90-5260 | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dilator, Vaginal | Panpac Medical Corporation | 13 |
| Intimate Rose | Plus EV Holdings Inc | 11 |
| Bioteque | Bioteque Taiwan Ltd. | 11 |
| Bioteque America, Inc. | Bioteque America, Inc. | 11 |
| Hayden Medical | Hayden Medical Inc | 4 |
| Medline | Medline Industries, Inc. | 3 |
| Milli Vaginal Dilator | Materna Medical | 3 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 3 |
| Orthomed | Ortho-MED, Inc. | 1 |
| Dilator, Vaginal | Doppkon Gmbh & Co. KG | 1 |
| Hope&Her Vaginal Dilators | Lujena, Inc. | 1 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 1 |
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.