Aesculap
HEGAR Uterine Dilator Set, consisting of EM099R, EM100R, EM101R, EM102R, EM103R, EM104R, EM105R, EM106R, EM107R, EM108R, EM109R, EM110R, EM111R, EM112R, EM113R, EM114R, EM11, non-sterile,…
HEGAR Uterine Dilator Set, consisting of EM099R, EM100R, EM101R, EM102R, EM103R, EM104R, EM105R, EM106R, EM107R, EM108R, EM109R, EM110R, EM111R, EM112R, EM113R, EM114R, EM11, non-sterile, reusable, Set
3manufacturers in China registered for this device type
98catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Wenzhou LW Wewear Accessories Co., Ltd. | Wenzhou | Zhejiang | Private-label distributor | 2 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | HDQ |
| Device type | Dilator, Cervical, Fixed Size |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-21 |
| Record revised | 2023-08-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EM112R | In distribution | |
| EM278R | In distribution | |
| MD068R | In distribution | |
| MB162R | In distribution | |
| EM276R | In distribution | |
| MG258R | In distribution | |
| MB173R | In distribution | |
| MG256R | In distribution | |
| EM143R | In distribution | |
| EM106R | In distribution | |
| EM125R | In distribution | |
| EM271R | In distribution | |
| MG592R | In distribution | |
| EM244R | In distribution | |
| MD067R | In distribution | |
| EM116R | In distribution | |
| EM134R | In distribution | |
| EM141R | In distribution | |
| MG254R | In distribution | |
| MG591R | In distribution | |
| MG593R | In distribution | |
| MB161R | In distribution | |
| MB164R | In distribution | |
| EM101R | In distribution | |
| EM139R | In distribution | |
| EM238R | In distribution | |
| EM237R | In distribution | |
| MD069R | In distribution | |
| EM145R | In distribution | |
| EM120R | In distribution | |
| EM234R | In distribution | |
| EM103R | In distribution | |
| EM113R | In distribution | |
| EM275R | In distribution | |
| EM122R | In distribution | |
| MG255R | In distribution | |
| EM104R | In distribution | |
| EM194R | In distribution | |
| EM193R | In distribution | |
| EM136R | In distribution | |
| MB168R | In distribution | |
| EM126R | In distribution | |
| EM140R | In distribution | |
| EM117R | In distribution | |
| EM274R | In distribution | |
| MG259R | In distribution | |
| MD064R | In distribution | |
| MG253R | In distribution | |
| EM121R | In distribution | |
| EM273R | In distribution | |
| EM235R | In distribution | |
| EM233R | In distribution | |
| EM142R | In distribution | |
| EM115R | In distribution | |
| EM138R | In distribution | |
| MD066R | In distribution | |
| EM102R | In distribution | |
| MB158R | In distribution | |
| EM105R | In distribution | |
| MB160R | In distribution | |
| EM132R | In distribution | |
| MG257R | In distribution | |
| EM272R | In distribution | |
| EM232R | In distribution | |
| MB167R | In distribution | |
| MB159R | In distribution | |
| EM108R | In distribution | |
| EM110R | In distribution | |
| MD065R | In distribution | |
| MB165R | In distribution | |
| EM239R | In distribution | |
| EM133R | In distribution | |
| EM109R | In distribution | |
| MG595R | In distribution | |
| MG252R | In distribution | |
| EM107R | In distribution | |
| MG596R | In distribution | |
| MB163R | In distribution | |
| MG251R | In distribution | |
| EM119R | In distribution | |
| EM146R | In distribution | |
| EM131R | In distribution | |
| EM236R | In distribution | |
| EM137R | In distribution | |
| EM147R | In distribution | |
| MB170R | In distribution | |
| EM124R | In distribution | |
| MB166R | In distribution | |
| EM114R | In distribution | |
| EM144R | In distribution | |
| EM111R | In distribution | |
| EM231R | In distribution | |
| MB169R | In distribution | |
| EM135R | In distribution | |
| EM277R | In distribution | |
| MG594R | In distribution | |
| EM123R | In distribution | |
| EM118R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hayden Medical | Hayden Medical Inc | 184 |
| Millennium | Avalign Technologies, Inc. | 181 |
| Elmed Incorporated | Elmed, Inc. | 152 |
| Marina Medical | Marina Medical Instruments, Inc. | 142 |
| Elmed | Elmed, Inc. | 138 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 129 |
| Ambler Surgical | Ambler Surgical, LLC | 103 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 100 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 77 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 73 |
| V. Mueller | Steris Corporation | 65 |
| Quinelato | Schobell Industrial Ltda | 55 |
Showing 12 of 104. All products under Dilator, Cervical, Fixed Size
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.