Delta-Cast Serene

FDA UDI

Class I (US FDA UDI)

by Bsn Medical, Inc.

Identity

Trade Name: Delta-Cast Serene FDA UDI
Generic Name: Cast cutter, electrically-powered FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 76289-00 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI: 04042809703535 FDA UDI
FDA Product Code: LGH FDA UDI
GMDN Term: Cast cutter, electrically-powered FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.5960 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cast cutter, electrically-powered

Delta-Cast Serene by Bsn Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Cast cutter, electrically-powered.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Bsn Medical, Inc.

Sources (1)

FDA UDI c6c126b1-1d6a-46a1-b4ab-478e2fe6990a 35 fields · synced Jun 1, 2026