Delta-Cast® Serene™ is a cast removal device that provides the needed power, precision, and ease of operation to cut Synthetic Casts that have been applied to a limb. Delta-Cast® Serene™ is…
Delta-Cast® Serene™ is a cast removal device that provides the needed power, precision, and ease of operation to cut Synthetic Casts that have been applied to a limb. Delta-Cast® Serene™ is intended to be used on patients for efficient removal of Synthetic Casts. Delta-Cast® Serene™ is an electrical device operated by an analog button and uses two rotary wheels (coggs) to pull a fixed blade through a synthetic casting material. The device can be operated in a forward or reverse direction with the use of a button.
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (2). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Delta-Cast Serene | Listed by | BSN Medical, Inc., United States |
| FDA product code | LGH |
| Device type | Instrument, Cast Removal, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 888.5960 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-03-07 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Handling environment humidity 20 to 90 % RH |
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.