FDA.reportPublic FDA data

OSCAR

Primary DI
05060201560548
Brand
OSCAR
Company
ORTHOSONICS LIMITED
Model
1
Catalog number
OHC2SO2060SU
Device description
Single Use 6mm Serrated Curved Osteotome – Sterile
Published
2017-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
05060201560548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060201560548050602015605485060201560548

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic orthopaedic cement extractorA hand-operated, electrically-powered surgical instrument that uses ultrasonic energy for the extraction of orthopaedic (bone) cement from a site of previous application, typically during the procedure to replace a previously cemented prosthesis. This GMDN code may include an aspirating device for the removal of cement/bone fragments. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width6Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
505987040
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
05060201560425OSCAR1OS30002017-07-10
05060201560432OSCAR1OH300/22017-07-10
05060201560449OSCAR1OHB300/22017-07-10
05060201560456OSCAR1CH3002017-07-10

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