FDA.reportPublic FDA data

Instrument

Primary DI
05060296236120
Brand
Instrument
Company
Stanmore Implants Worldwide Ltd
Model
JTS-FACE
Catalog number
JTS-FACE
Device description
Face Cutter Body & Spigot
Published
2019-07-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060296236120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060296236120050602962361205060296236120

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
494989502
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060296233839InstrumentimgenimpIMGENIMP2019-07-18
05060296233853Instrumentimpbimp/StdIMPBIMP-STD2019-07-18
05060296233877Instrumentimpbimp/SmIMPBIMP-SM2019-07-18
05060296236182Instrumentimpbimp/ExSmIMPBIMP-EXSM2019-07-18
05060296233693InstrumentimcirprIMCIRPR2019-07-18
05060296236397InstrumentibnpinPINS2019-07-18
05060296233709InstrumentimtrfhIMTRFH2019-07-18
05060296233761Instrumentimtrrhm/StdIMTRRHM-STD2019-07-18
05060296233778Instrumentimtrrhm/SmIMTRRHM-SM2019-07-18
05060296233846Instrumentimtrrhp/SmIMTRRHP-SM2019-07-18
05060296233860Instrumentimtrrhp/StdIMTRRHP-STD2019-07-18
05060296236151Instrumentimtrrhm/ExSmIMTRRHM-EXSM2019-07-18
05060296236175Instrumentimtrrhp/ExSmIMTRRHP-EXSM2019-07-18
05060296236304Instrumentimtrp/ExSmIMTRP-EXSM2019-07-18
05060296236311Instrumentimtrp/SmIMTRP-SM2019-07-18
05060296236328Instrumentimtrp/StdIMTRP-STD2019-07-18
05060296230272Stanmoremktp/Sm5MKTP-SM52019-07-18
05060296230289Stanmoremktp/Sm10MKTP-SM102019-07-18
05060296230296Stanmoremktp/Sm15MKTP-SM152019-07-18
05060296230302Stanmoremktp/Sm20MKTP-SM202019-07-18

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Primary DI, Brand, Company table
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