Gynex
36 catalogue numbers from 4212, listed by Gynex Corporation, United States, under Dilator, Cervical, Fixed Size. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
36catalogue 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 | Gynex Corporation, United States |
|---|---|
| FDA product code | HDQ |
| Device type | Dilator, Cervical, Fixed Size |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-12-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4212 | 12 | In distribution | |
| 4222 | 24 | In distribution | |
| 4005.4 | In distribution | ||
| 4230 | In distribution | ||
| 4010 | In distribution | ||
| 4202 | In distribution | ||
| 4010.4.5 | In distribution | ||
| 4255 | 12 | In distribution | |
| 4008 | In distribution | ||
| 4010.7.5 | In distribution | ||
| 4010.6.5 | In distribution | ||
| DPU3850 | In distribution | ||
| DHU3800 | In distribution | ||
| 4223 | 24 | In distribution | |
| 4008.2 | In distribution | ||
| 4005 | In distribution | ||
| 4008.4 | In distribution | ||
| 4008.5 | In distribution | ||
| 4200 | In distribution | ||
| 4005.1.5 | In distribution | ||
| 4008.3 | In distribution | ||
| 4005.2.5 | In distribution | ||
| 4245 | 12 | In distribution | |
| 4201 | In distribution | ||
| 4008.6 | In distribution | ||
| 4250 | 12 | In distribution | |
| 4213 | 12 | In distribution | |
| 4203 | In distribution | ||
| 4010.9.5 | In distribution | ||
| 4010.5.5 | In distribution | ||
| 4008.1 | In distribution | ||
| 4221 | 24 | In distribution | |
| 4005.5 | In distribution | ||
| 4211 | 12 | In distribution | |
| 4010.8.5 | In distribution | ||
| 4240 | 12 | 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.