FDA.reportPublic FDA data

Medtronic Cases and Trays

Primary DI
00721902957093
Brand
Medtronic Cases and Trays
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7059532
Device description
CASE 7059532 LEG STANDARD HOOK MOD TI
Published
2023-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KTCBath, sitz, nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KTCBath, Sitz, NonpoweredPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152241000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152241000Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc.2016-01-20KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00721902957093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00721902957093007219029570937219029570930721902957093

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150076161Medtronic Reusable InstrumentsX02260412026-06-05
00199150076178Medtronic Reusable InstrumentsX02260422026-06-05
00199150080304Medtronic Reusable InstrumentsX08032922026-06-05
00199150077359Medtronic Reusable InstrumentsEX02260492026-06-01
00199150077366Medtronic Reusable InstrumentsEX02260512026-06-01
00763000857844T2 STRATOSPHERE™ Expandable Corpectomy System43612552026-06-01
00763000857943T2 STRATOSPHERE™ Expandable Corpectomy System43612202026-06-01
00763000857998T2 STRATOSPHERE™ Expandable Corpectomy System43613082026-06-01
00763000881252Clydesdale™ Spinal System49860402026-05-29
00199150073504Medtronic Reusable InstrumentsEX12250012026-05-25
00199150071685Medtronic Reusable InstrumentsEX02261402026-05-24
00199150071692Medtronic Reusable InstrumentsEX02261502026-05-24
00199150071708Medtronic Reusable InstrumentsEX02261602026-05-24
00199150071715Medtronic Reusable InstrumentsEX02261702026-05-24
00199150071722Medtronic Reusable InstrumentsEX02261802026-05-24
00199150071739Medtronic Reusable InstrumentsEX02261902026-05-24
00199150071746Medtronic Reusable InstrumentsEX02262002026-05-24
00199150071753Medtronic Reusable InstrumentsEX02260402026-05-24
00199150071760Medtronic Reusable InstrumentsEX02260502026-05-24
00199150071777Medtronic Reusable InstrumentsEX02260602026-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974021412637equate sitz bathWAL-MART STORES, INC.KTC2025-10-08
00661392012547LSL HEALTHCARELSL Industries, LLCKTC2025-05-16
10661392012544LSL HEALTHCARELSL Industries, LLCKTC2025-05-16
07392532279409DS PrimeTaperDentsply Implants Manufacturing GmbHKTC2024-06-03
07392532279416DS PrimeTaperDentsply Implants Manufacturing GmbHKTC2024-06-03
07350016060035Ecoline with mixer, 50 MM DRAIN, H=80 CMTr Equipment ABKTC2023-12-12
07350016060141TR1700 HI LO 230V incl. Mixer and showerTr Equipment ABKTC2023-12-12
07350016060189TR900CW HI LO 230V Cleaning & WhirlpoolTr Equipment ABKTC2023-12-12
07350016060196TR900CWA HI LO 230V Cleaning, Autofill & WhirlpoolTr Equipment ABKTC2023-12-12
07350016061414TR900C HI LO 230V Cleaning GETr Equipment ABKTC2023-12-12
07350016061421TR900C HI LO 110V Cleaning USTr Equipment ABKTC2023-12-12
07350016061438TR900CW HI LO 230V Cleaning & Whirlpool UK TMV3Tr Equipment ABKTC2023-12-12
07350016061445TR900CW HI LO 110V Cleaning & Whirlpool USTr Equipment ABKTC2023-12-12
07350016061452TR900CW HI LO 230V Cleaning & Whirlpool GETr Equipment ABKTC2023-12-12
07350016061469TR900A HI LO 230V Autofill Tr Equipment ABKTC2023-12-12
07350016061476TR900A HI LO 230V Autofill GETr Equipment ABKTC2023-12-12
07350016061483TR900A HI LO 230V Autofill UK TMV3Tr Equipment ABKTC2023-12-12
07350016061490TR900CA HI LO 230V Cleaning & Autofill Tr Equipment ABKTC2023-12-12
07350016061506TR900CA HI LO 230V Cleaning & Autofill GETr Equipment ABKTC2023-12-12
07350016061513TR900CA HI LO 110V Cleaning & Autofill USTr Equipment ABKTC2023-12-12
07350016061520TR900CWA HI LO 230V Cleaning, Autofill & Whirlpool GETr Equipment ABKTC2023-12-12
07350016061537TR900CWA HI LO 110V Cleaning, Autofill & Whirlpool USTr Equipment ABKTC2023-12-12
07350016061544TR900CW Fixed height 230VTr Equipment ABKTC2023-12-12
07350016061551TR900CW Fixed height 110V USTr Equipment ABKTC2023-12-12
07350016061568Hilo Bath TR 900 With Stainless BathtubTr Equipment ABKTC2023-12-12
07350016061575Hilo Bath TR 900 TMV3, With Stainless BathtubTr Equipment ABKTC2023-12-12
07350016061582Hilo Bath TR 900 US With Stainless BathtubTr Equipment ABKTC2023-12-12
07350016061599Hilo Bath TR 900 A, With Stainless BathtubTr Equipment ABKTC2023-12-12
07350016061605Hilo Bath TR 900 A TMV3, Stainless BathtubTr Equipment ABKTC2023-12-12
07350016061612COMFORTLINE II, BATHTUB,40 MM DRAIN, TMV3Tr Equipment ABKTC2023-12-12