Dilator, Vaginal
"Panpac Vaginal Dilators are indicated for women who need vaginal dilation for an examination, a surgical procedure, or for the relief of vaginismus. Panpac Vaginal Dilators has four…
“Panpac Vaginal Dilators are indicated for women who need vaginal dilation for an examination, a surgical procedure, or for the relief of vaginismus. Panpac Vaginal Dilators has four different size (small, medium, large and extra large) in three family types; Family A, Family B and Family C with variant sizes. “
1manufacturer
13catalogue numbers in this listing
1510(k) clearance
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 | Panpac Medical Corporation, Taiwan |
|---|---|
| FDA product code | HDX |
| Device type | Dilator, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3900 |
| Record published | 2016-09-10 |
| Record revised | 2022-11-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DT-A/L | In distribution | |
| DT-A/XL | In distribution | |
| DT-B/XL | In distribution | |
| DT-C | In distribution | |
| DT-A/M | In distribution | |
| DT-B-W | In distribution | |
| DT-A-W | In distribution | |
| DT-B/M | In distribution | |
| DT-B/L | In distribution | |
| DT-A | In distribution | |
| DT-A/S | In distribution | |
| DT-B | In distribution | |
| DT-B/S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130273 | 2013-08-08 |
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.