FDA.reportPublic FDA data

Instrument

Primary DI
05060296236472
Brand
Instrument
Company
Stanmore Implants Worldwide Ltd
Model
TGBI-KTCG
Catalog number
TGBI-10
Device description
Customs Tibial Cutting Guide Tray
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

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060296236472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060296236472050602962364725060296236472

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for placing/containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during, but not dedicated to, reprocessing/sterilization procedures. It may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
494989502
Device count
1
Premarket exempt
true
Serial number
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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