Hayden Medical
Pratt Uterine Dilators - (Set of 8 in a Khaki Roll) 13/15 Fr. (4.3/5.0mm) - 41/43 Fr. (13.7/14.3mm), 11-1/2" (28.8cm), double ended
3manufacturers in China registered for this device type
184catalogue 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 | Hayden Medical Inc, 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 | 2023-03-21 |
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, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 295-522 | In distribution | |
| 290-125 | In distribution | |
| 290-169 | In distribution | |
| 290-313 | In distribution | |
| 290-159 | In distribution | |
| 290-198 | In distribution | |
| 290-233K | In distribution | |
| 290-155 | In distribution | |
| 290-317XXL | In distribution | |
| 290-103 | In distribution | |
| 290-231K | In distribution | |
| 290-337XXL | In distribution | |
| 290-103-12 | In distribution | |
| 290-341 | In distribution | |
| 290-317 | In distribution | |
| 290-341XXL | In distribution | |
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| 290-243 | In distribution | |
| 290-241K | In distribution | |
| 290-119 | In distribution | |
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| 290-156 | In distribution | |
| 290-404 | In distribution | |
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| 290-325XXL | In distribution | |
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| 290-105-12 | In distribution | |
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Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.