Pratt Ex Large, Light Weight
Pratt Ex large, Light Weight 53-55 Fr (17.6-18.3 mm)
3manufacturers in China registered for this device type
9catalogue 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 |
|---|---|---|
| Pratt Ex large, Light Weight 53-55 Fr (17.6-18.3 mm) | In distribution | |
| Pratt Ex large, Light Weight 69-71 Fr (23-23.6 mm) | In distribution | |
| Pratt Ex large, Light Weight 77-79 Fr (25.6-26.3 mm) | In distribution | |
| Pratt Ex large, Light Weight 61-63 Fr (20.3-21 mm) | In distribution | |
| Pratt Ex large, Light Weight 73-75 Fr (24.3-25 mm) | In distribution | |
| Pratt Ex large, Light Weight 49-51 Fr (16.3-17 mm) | In distribution | |
| Pratt Ex large, Light Weight 45-47 Fr (15-15.6 mm) | In distribution | |
| Pratt Ex large, Light Weight 65-67 Fr (21.6-22.3 mm) | In distribution | |
| Pratt Ex large, Light Weight 57-59 Fr (19-19.6 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.