Hayden Medical
Henning Cast Spreader 11" (27.9cm), 2" (5.1cm) wide blades
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (2), Shandong (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 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Shengzhou City Sike NEW Materials Technology Co., Ltd. | Shengzhou | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Hayden Medical Inc, United States |
|---|---|
| FDA product code | LGG |
| Device type | Instrument, Cast Application/Removal, Manual |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5980 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2023-03-14 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 270-094 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Miltex® | Integra LifeSciences Production Corporation | 32 |
| Sklar® | Sklar Corporation | 22 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 18 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 10 |
| Novo Surgical | Novo Surgical, Inc. | 9 |
| Kmedic | Teleflex Medical LLC | 8 |
| Aesculap | Aesculap AG | 7 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 7 |
| Millennium | Avalign Technologies, Inc. | 7 |
| Ambler Surgical | Ambler Surgical, LLC | 6 |
| HNM Medical | HNM Stainless, LLC. | 5 |
| McKesson | Mckesson Medical-Surgical Inc. | 5 |
Showing 12 of 32. All products under Instrument, Cast Application/Removal, Manual
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.