Integra® Miltex®
Integra® Miltex® SILICONE VAGINAL DILATOR SET MEDIUM SET OF 4 SIZES
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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | HDX |
| Device type | Dilator, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3900 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| 510(k) | K003380 |
| Record published | 2016-08-26 |
| Record revised | 2023-05-02 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30-3002 | In distribution | |
| 30-3003 | In distribution | |
| 30-3001 | 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 |
| Sklar® | Sklar Corporation | 3 |
| Medline | Medline Industries, Inc. | 3 |
| Milli Vaginal Dilator | Materna Medical | 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.