FDA.reportPublic FDA data

OSCAR

Primary DI
05060201560425
Brand
OSCAR
Company
ORTHOSONICS LIMITED
Model
1
Catalog number
OS3000
Device description
Ultrasonic Generator
Published
2017-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDXInstrument, Surgical, Sonic And Accessory/Attachment
LZVSystem, Cement Removal Extraction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDXInstrument, Surgical, Sonic And Accessory/AttachmentOrthopedic2
LZVSystem, Cement Removal ExtractionOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060201560425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060201560425050602015604255060201560425

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement extractor, electricA hand-operated, electrically-powered surgical instrument designed to extract orthopaedic (bone) cement from a site of previous application, typically during the procedure to replace a previously cemented prosthesis. This GMDN code may include slide hammers, chisels, or other power operated devices which are intended to be used to break up the bone cement for removal. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4401628594500enquiries@orthosonics.co.uk

Regulatory Flags#

DUNS number
505987040
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060201560036OSCAR1OH3002017-07-10
05060201560074OSCAR1OC2012017-07-10
05060201560081OSCAR1OGC3002017-07-10
05060201560098OSCAR1OHC3002017-07-10
05060201560173OSCAR1IPL2002017-07-10
05060201560258OSCAR1OHE20002017-07-10
05060201560302OSCAR1OHS2080SU2017-07-10
05060201560319OSCAR1OHP2080SU2017-07-10
05060201560326OSCAR1OHP218FSU2017-07-10
05060201560333OSCAR1 EXP2681SU2017-07-10
05060201560340OSCAR1OHS2062SU2017-07-10
05060201560357OSCAR1OHP2062SU2017-07-10
05060201560364OSCAR1OHP2100SU2017-07-10
05060201560371OSCAR1OHS2100SU2017-07-10
05060201560388OSCAR1 OHA2030SU2017-07-10
05060201560395OSCAR1OHR20002017-07-10
05060201560432OSCAR1OH300/22017-07-10
05060201560449OSCAR1OHB300/22017-07-10
05060201560456OSCAR1CH3002017-07-10
05060201560463OSCAR1ORFS3002017-07-10

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Primary DI, Brand, Company table
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08404535024340Axiom BladesPeter Brasseler Holdings, LLCLZV2026-04-29
08404535024371Axiom BladesPeter Brasseler Holdings, LLCLZV2026-04-29
08404535024401Axiom BladesPeter Brasseler Holdings, LLCLZV2026-04-29
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E322036300090MECTRONMECTRON SPAJDX2026-04-20
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