Avalign
Hank Uterine Dilator, Set of 6, double ended, 9-10fr thru 19-20fr, OL 270mm(10 3/4") in canvas roll
3manufacturers in China registered for this device type
47catalogue 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 | Avalign Technologies, 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, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-11-03 |
| Record revised | 2023-07-06 (version 2) |
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 |
| Distribution end date | 2023-09-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VM57-3132 | In distribution | |
| VM57-3124 | In distribution | |
| VM57-3173 | In distribution | |
| VM57-3199 | In distribution | |
| VM57-3107 | In distribution | |
| VM57-3119 | In distribution | |
| VM57-3183 | In distribution | |
| VM57-3179 | In distribution | |
| VM57-3114 | In distribution | |
| VM57-3122 | In distribution | |
| VM57-3131 | In distribution | |
| VM57-3152 | In distribution | |
| VM57-3257 | In distribution | |
| VM57-3215 | In distribution | |
| VM57-31402 | In distribution | |
| VM57-3118 | In distribution | |
| VM57-3331 | In distribution | |
| VM57-31404 | In distribution | |
| VM57-3117 | In distribution | |
| VM57-3148 | In distribution | |
| VM57-31403 | In distribution | |
| VM57-3144 | In distribution | |
| VM57-3133 | In distribution | |
| VM57-3171 | In distribution | |
| VM57-3145 | In distribution | |
| VM57-3259 | In distribution | |
| VM56-4881 | In distribution | |
| VM57-3258 | In distribution | |
| VM57-3110 | In distribution | |
| VM57-3175 | In distribution | |
| VM57-3191 | In distribution | |
| VM57-3120 | In distribution | |
| VM57-3113 | In distribution | |
| VM57-3142 | In distribution | |
| VM57-3116 | In distribution | |
| VM57-3149 | In distribution | |
| VM57-3211 | In distribution | |
| VM57-3140 | In distribution | |
| VM57-3187 | In distribution | |
| VM57-3110-3 | In distribution | |
| VM57-3143 | In distribution | |
| VM57-3146 | In distribution | |
| VM57-3115 | In distribution | |
| VM57-3103 | In distribution | |
| VM57-3195 | In distribution | |
| VM57-3111 | In distribution | |
| VM57-31405 | Withdrawn |
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.