BR Surgical, LLC
PRATT Uterine Dilators, set of 8, (13/15Fr, 17/19Fr, 21/23Fr, 25/27Fr, 29/31Fr, 33/35Fr, 37/39Fr, 41/43Fr)
3manufacturers in China registered for this device type
54catalogue 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 | BR Surgical LLC, 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 |
| Premarket notification | Exempt |
| Record published | 2023-05-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BR70-41001 | In distribution | |
| BR70-42013 | In distribution | |
| BR70-41006 | In distribution | |
| BR70-43506 | In distribution | |
| BR70-43012 | In distribution | |
| BR70-41008 | In distribution | |
| BR70-41003 | In distribution | |
| BR70-43023 | In distribution | |
| BR70-42000 | In distribution | |
| BR70-43800 | In distribution | |
| BR70-41501 | In distribution | |
| BR70-43831 | In distribution | |
| BR70-43021 | In distribution | |
| BR70-41505 | In distribution | |
| BR70-42009 | In distribution | |
| BR70-43008 | In distribution | |
| BR70-43016 | In distribution | |
| BR70-43020 | In distribution | |
| BR70-41015 | In distribution | |
| BR70-43817 | In distribution | |
| BR70-42126 | In distribution | |
| BR70-43813 | In distribution | |
| FG70-71438-21 | In distribution | |
| BR70-43025 | In distribution | |
| BR70-41000 | In distribution | |
| BR70-43014 | In distribution | |
| BR70-41002 | In distribution | |
| BR70-41020 | In distribution | |
| BR70-42015 | In distribution | |
| BR70-41013 | In distribution | |
| BR70-41007 | In distribution | |
| FG70-71438-17 | In distribution | |
| BR70-43821 | In distribution | |
| BR70-44134 | In distribution | |
| BR70-41504 | In distribution | |
| BR70-41506 | In distribution | |
| BR70-43833 | In distribution | |
| FG70-71438-13 | In distribution | |
| BR70-41503 | In distribution | |
| BR70-41502 | In distribution | |
| BR70-42011 | In distribution | |
| BR70-41005 | In distribution | |
| BR70-41010 | In distribution | |
| BR70-43825 | In distribution | |
| BR70-42003 | In distribution | |
| BR70-43018 | In distribution | |
| BR70-41004 | In distribution | |
| BR70-41507 | In distribution | |
| BR70-43010 | In distribution | |
| BR70-42007 | In distribution | |
| BR70-42005 | In distribution | |
| BR70-41009 | In distribution | |
| BR70-40057 | In distribution | |
| BR70-42001 | 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.