FDA.reportPublic FDA data

TSI Instrument Tray

Primary DI
09348215072599
Brand
TSI Instrument Tray
Company
SIGNATURE ORTHOPAEDICS PTY LTD
Model
112-28-0075
Published
2020-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181340000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181340000Cemented TSI Hip StemSignature Orthopaedics Pty, Ltd.2019-02-11JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09348215072599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09348215072599093482150725999348215072599

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
751993028
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09348215185428Signature Magnum Acetabular Cup111-67-00442026-07-29
09348215185435Signature Magnum Acetabular Cup111-67-00462026-07-29
09348215185442Signature Magnum Acetabular Cup111-67-00482026-07-29
09348215185459Signature Magnum Acetabular Cup111-67-00502026-07-29
09348215185466Signature Magnum Acetabular Cup111-67-00522026-07-29
09348215185473Signature Magnum Acetabular Cup111-67-00542026-07-29
09348215185480Signature Magnum Acetabular Cup111-67-00562026-07-29
09348215185497Signature Magnum Acetabular Cup111-67-00582026-07-29
09348215185503Signature Magnum Acetabular Cup111-67-00602026-07-29
09348215185510Signature Magnum Acetabular Cup111-67-00622026-07-29
09348215185527Signature Magnum Acetabular Cup111-67-00642026-07-29
09348215185534Signature Magnum Acetabular Cup111-67-00662026-07-29
09348215185541Signature Resurfacing Femoral Head111-67-01382026-07-29
09348215185558Signature Resurfacing Femoral Head111-67-01402026-07-29
09348215185565Signature Resurfacing Femoral Head111-67-01422026-07-29
09348215185572Signature Resurfacing Femoral Head111-67-01442026-07-29
09348215185589Signature Resurfacing Femoral Head111-67-01462026-07-29
09348215185596Signature Resurfacing Femoral Head111-67-01482026-07-29
09348215185602Signature Resurfacing Femoral Head111-67-01502026-07-29
09348215185619Signature Resurfacing Femoral Head111-67-01522026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810068850079Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850086Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850093Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850109Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850123Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850130Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850147Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850154Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850185Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850192Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850208Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850215Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850222Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850239Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850246Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850284Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850307Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850321Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850338Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850345Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850635Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850642Biocore9 Acetabular Cup SystemBiocore9, LLCJDI2026-06-26
00810068850703Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850710Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850727Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850734Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850741Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850758Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850772Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26
00810068850895Biocore9 Acetabular Bearing SystemBiocore9, LLCJDI2026-06-26