McKesson.
Speculum, Vaginal, Non-Metal
40manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (15), Zhejiang (15), Shanghai (5). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Linhai Deyi Plastic Co., Ltd. | Linhai | Zhejiang | Contract manufacturer | 15 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
Showing 12 of 40. All 40 manufacturers in China registered for Speculum, Vaginal, Nonmetal
Record
| Listed by | Mckesson Medical-Surgical Inc. |
|---|---|
| FDA product code | HIB |
| Device type | Speculum, Vaginal, Nonmetal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| 510(k) | K050887 |
| Record published | 2016-12-09 |
| Record revised | 2018-07-06 (version 3) |
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, manufacturing date |
| Packaging | Case of 10, case of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 211 | 10 | In distribution | |
| 16-8313 | 25 | In distribution | |
| 11-8310 | 10 | In distribution | |
| 16-8312 | 25 | In distribution | |
| 11-8309 | 10 | In distribution | |
| 209 | 10 | In distribution | |
| 16-8314 | 25 | In distribution | |
| 210 | 10 | In distribution | |
| 200-C/A | 25 | In distribution | |
| 11-8311 | 10 | In distribution | |
| 100-C/A | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 30 |
| Vagispec Kolplast | Kolplast C I | 19 |
| EOS | North EOS Industries, Inc. | 19 |
| Shengbo | Yuhuan City Shengbo Mould Manufacturing Co., Ltd. | 18 |
| Centurion | Centurion Medical Products Corporation | 13 |
| ClearSpec | Clearspec, LLC | 12 |
| Speculux | Evexar Medical Limited | 12 |
| Instraspec | Robinson Healthcare Limited | 10 |
| PremierPro | Prestige Ameritech | 9 |
| Bioseal Inc. | Bioseal | 9 |
| ER-Spec/Office-Spec | OBP Medical Corporation | 6 |
| Medline | Medline Industries, Inc. | 6 |
Showing 12 of 75. All products under Speculum, Vaginal, Nonmetal
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | 510(k) number | 2015-04-13 | Class II | Packaging change control | Small sized specula were incorrectly packaged in printed bags for the medium sized speculum | 9400 units | 2016-02-05 |
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.