Delta-Cast Serene

Basic Information

• Brand Name: Delta-Cast Serene
• Primary DI: 04042809703535
• Version / Model: 76289-00
• Company Name: BSN MEDICAL, INC.
• Labeler DUNS: 026301221
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-07
• Public Version: 1
• Public Version Date: 2025-03-17
• Public Version Status: New
• Public Device Record Key: c6c126b1-1d6a-46a1-b4ab-478e2fe6990a

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LGH	Instrument, Cast Removal, Ac-Powered	Orthopedic	888.5960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16340	Cast cutter, electrically-powered	A hand-held, electrically-powered device designed for cutting the plaster or synthetic material used to form casts typically during the removal process. The proximal end is usually cylindrical, forming the handle of the device, whilst the distal end terminates in a rounded, half moon-like, or circular blade capable of cutting the material used to form casts. The cutting capability of the blade is provided by an electric motor in the handle which vibrates or rotates the blade. Cutting is effected by vibration or rotation rather than sawing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04042809703535	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity