Delta-Cast Serene

GUDID 04042809721966

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.

BSN MEDICAL, INC.

Cast cutter, electrically-powered

• Primary Device ID: 04042809721966
• NIH Device Record Key: 0fc85cda-8648-4677-92fc-d216af9f5cde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Delta-Cast Serene
• Version Model Number: 74470-50
• Company DUNS: 026301221
• Company Name: BSN MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)537-1063
• Email: HMS.ORDERS@ESSITY.COM
• Phone: +1(800)537-1063
• Email: HMS.ORDERS@ESSITY.COM
• Phone: +1(800)537-1063
• Email: HMS.ORDERS@ESSITY.COM
• Phone: +1(800)537-1063
• Email: HMS.ORDERS@ESSITY.COM
• Phone: +1(800)537-1063
• Email: HMS.ORDERS@ESSITY.COM
• Phone: +1(800)537-1063
• Email: HMS.ORDERS@ESSITY.COM
• Phone: +1(800)537-1063
• Email: HMS.ORDERS@ESSITY.COM
• Phone: +1(800)537-1063
• Email: HMS.ORDERS@ESSITY.COM
• Phone: +1(800)537-1063
• Email: HMS.ORDERS@ESSITY.COM
• Phone: +1(800)537-1063
• Email: HMS.ORDERS@ESSITY.COM
• Phone: +1(800)537-1063
• Email: HMS.ORDERS@ESSITY.COM
• Phone: +1(800)537-1063
• Email: HMS.ORDERS@ESSITY.COM
• Phone: +1(800)537-1063
• Email: HMS.ORDERS@ESSITY.COM
• Phone: +1(800)537-1063
• Email: HMS.ORDERS@ESSITY.COM
• Phone: +1(800)537-1063
• Email: HMS.ORDERS@ESSITY.COM

Operating and Storage Conditions

• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04042809721966 [Primary]

FDA Product Code

• LGH: Instrument, Cast Removal, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-17
• Device Publish Date: 2025-03-07

On-Brand Devices [Delta-Cast Serene]

• 04042809721966: Delta-Cast® Serene™ is a cast removal device that provides the needed power, precision, and e
• 04042809703535: Delta-Cast® Serene™ is a cast removal device that provides the needed power, precision, and e