Hern Dilator
Hern Dilator 113Fr (37.6 mm)
3manufacturers in China registered for this device type
24catalogue 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 | Medgyn Products, Inc., United States |
|---|---|
| FDA product code | HDQ |
| Device type | Dilator, Cervical, Fixed Size |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-04-16 |
| Record revised | 2026-06-29 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Hern Dilator 68Fr (22.6 mm) | In distribution | |
| Hern Dilator 80Fr (26.6 mm) | In distribution | |
| Hern Dilator 113Fr (37.6 mm) | In distribution | |
| Hern Dilator 83Fr (27.6 mm) | In distribution | |
| Hern Dilator 101Fr (33.6 mm) | In distribution | |
| Hern Dilator 110Fr (36.6 mm) | In distribution | |
| Hern Dilator 95Fr (31.6 mm) | In distribution | |
| Hern Dilator 98Fr (32.6 mm) | In distribution | |
| Hern Dilator 77Fr (25.6 mm) | In distribution | |
| Hern Dilator 47Fr (15.6 mm) | In distribution | |
| Hern Dilator 62Fr (20.6 mm) | In distribution | |
| Hern Dilator 71Fr (23.6 mm) | In distribution | |
| Hern Dilator 104Fr (34.6 mm) | In distribution | |
| Hern Dilator 65Fr (21.6 mm) | In distribution | |
| Hern Dilator 107Fr (35.6 mm) | In distribution | |
| Hern Dilator 56Fr (18.6 mm) | In distribution | |
| Hern Dilator 53Fr (17.6 mm) | In distribution | |
| Hern Dilator 89Fr (29.6 mm) | In distribution | |
| Hern Dilator 59Fr (19.6 mm) | In distribution | |
| Hern Dilator 86Fr (28.6 mm) | In distribution | |
| Hern Dilator 50Fr (16.6 mm) | In distribution | |
| Hern Dilator 74Fr (24.6 mm) | In distribution | |
| Hern Dilator 44Fr (14.6 mm) | In distribution | |
| Hern Dilator 92Fr (30.6 mm) | 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 |
| Aesculap | Aesculap AG | 98 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 77 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 73 |
| V. Mueller | Steris Corporation | 65 |
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.