FDA.reportPublic FDA data

Delta-Cast Serene

Primary DI
04042809721966
Brand
Delta-Cast Serene
Company
BSN MEDICAL, INC.
Model
74470-50
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.
Published
2025-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGHInstrument, Cast Removal, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGHInstrument, Cast Removal, Ac-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042809721966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042809721966040428097219664042809721966

GMDN Terms#

Term, Definition table
TermDefinition
Cast cutter, electrically-poweredA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)537-1063HMS.ORDERS@ESSITY.COM

Regulatory Flags#

DUNS number
026301221
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00035664600266JOBST Custom Seamed75074-0075074-002026-05-11
00035664600273JOBST Custom Seamed75074-0175074-012026-05-11
00035664600860JOBST Custom Seamed75065-0075065-002026-05-11
00035664600891JOBST Custom Seamed75066-0075066-002026-05-11
00035664601089JOBST Custom Seamed75067-0075067-002026-05-11
00035664601348JOBST Custom Seamed75064-0075064-002026-05-11
00035664601355JOBST Custom Seamed75064-0175064-012026-05-11
00035664601423JOBST Custom Seamed75071-0075071-002026-05-11
00035664601430JOBST Custom Seamed75071-0175071-012026-05-11
00035664601447JOBST Custom Seamed75071-0275071-022026-05-11
00035664601454JOBST Custom Seamed75072-0075072-002026-05-11
00035664601461JOBST Custom Seamed75071-0675071-062026-05-11
00035664601478JOBST Custom Seamed75071-0775071-072026-05-11
00035664601508JOBST Custom Seamed75071-0375071-032026-05-11
00035664601515JOBST Custom Seamed75071-0475071-042026-05-11
00035664601522JOBST Custom Seamed75071-0575071-052026-05-11
04042809633061JOBST Sport752896175289612018-06-30
04042809633146JOBST Sport752906175290612018-06-30
04042809649277ZONAS® by Actimove®65001-0465001-042025-09-02
04042809818574ZONAS® by Actimove®65001-0165001-012025-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051471208803De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2025-06-17
05060528013192De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2025-05-14
05060528013208De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2025-05-14
05060528013215De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2025-05-14
05060528013222De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2025-05-14
04042809703535Delta-Cast SereneBSN MEDICAL, INC.LGH2025-03-07
05051471208773De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2024-02-01
05051471208780De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2024-02-01
05051471208797De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2024-02-01
05051471000513De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471000766De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471000773De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471001398De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471001824De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471005198De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471005204De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006355De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006362De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006379De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006386De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006409De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471006959De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471009646De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471011458De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471011465De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471012332De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471015364De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471015432De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471016163De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25
05051471018693De Soutter MedicalDE SOUTTER MEDICAL LIMITEDLGH2022-11-25