FDA.reportPublic FDA data

N/A

Primary DI
00643169019263
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7069035
Device description
TRAY 7069035 CDHS 5.5 NON-BO 3/4
Published
2017-11-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190840000Medtronic Transportation / Sterilization CassettesMedtronic Sofamor Danek USA, Inc.2019-10-15KCT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169019263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169019263006431690192636431690192630643169019263

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. 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
00199150002139N/A593250132026-07-16
00199150002146N/A593250162026-07-16
00199150015832INFINITY™ Occipitocervical Upper Thoracic System365370252026-07-16
00199150015849INFINITY™ Occipitocervical Upper Thoracic System365370302026-07-16
00199150015856INFINITY™ Occipitocervical Upper Thoracic System365370352026-07-16
00199150015863INFINITY™ Occipitocervical Upper Thoracic System365370402026-07-16
00199150015870INFINITY™ Occipitocervical Upper Thoracic System365370452026-07-16
00199150015887INFINITY™ Occipitocervical Upper Thoracic System365370502026-07-16
00199150015894INFINITY™ Occipitocervical Upper Thoracic System365370552026-07-16
00199150015900INFINITY™ Occipitocervical Upper Thoracic System365370602026-07-16
00199150015917INFINITY™ Occipitocervical Upper Thoracic System365370652026-07-16
00199150015924INFINITY™ Occipitocervical Upper Thoracic System365370702026-07-16
00199150015931INFINITY™ Occipitocervical Upper Thoracic System365370752026-07-16
00199150015948INFINITY™ Occipitocervical Upper Thoracic System365370802026-07-16
00199150015955INFINITY™ Occipitocervical Upper Thoracic System365370852026-07-16
00199150015962INFINITY™ Occipitocervical Upper Thoracic System365370902026-07-16
00199150015986INFINITY™ Occipitocervical Upper Thoracic System365371002026-07-16
00199150016006INFINITY™ Occipitocervical Upper Thoracic System365371102026-07-16
00199150016013INFINITY™ Occipitocervical Upper Thoracic System365371202026-07-16
00199150016037INFINITY™ Occipitocervical Upper Thoracic System365350602026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630008405793APTUSMedartis AGFSM2026-07-16
07630008405809APTUSMedartis AGFSM2026-07-16
07630008405878APTUSMedartis AGFSM2026-07-16
07630008405892APTUSMedartis AGFSM2026-07-16
07630008406226APTUSMedartis AGFSM2026-07-16
07630008406233APTUSMedartis AGFSM2026-07-16
07630008406240APTUSMedartis AGFSM2026-07-16
07630008406257APTUSMedartis AGFSM2026-07-16
07630008406264APTUSMedartis AGFSM2026-07-16
07630008406271APTUSMedartis AGFSM2026-07-16
07630008406288APTUSMedartis AGFSM2026-07-16
07630008406295APTUSMedartis AGFSM2026-07-16
07630008406301APTUSMedartis AGFSM2026-07-16
07630008406318APTUSMedartis AGFSM2026-07-16
07630008406325APTUSMedartis AGFSM2026-07-16
07630008406332APTUSMedartis AGFSM2026-07-16
07630008428327APTUSMedartis AGFSM2026-07-16
07630008428334APTUSMedartis AGFSM2026-07-16
07630008453206APTUSMedartis AGFSM2026-07-16
07630008488284APTUSMedartis AGFSM2026-07-16
07630008488314APTUSMedartis AGFSM2026-07-16
07630008488406APTUSMedartis AGFSM2026-07-16
07630037833475APTUSMedartis AGFSM2026-07-16
07630037833482APTUSMedartis AGFSM2026-07-16
07630037846437APTUSMedartis AGFSM2026-07-16
07630037846444APTUSMedartis AGFSM2026-07-16
07630037846697APTUSMedartis AGFSM2026-07-16
07630037846802APTUSMedartis AGFSM2026-07-16
07630037847229APTUSMedartis AGFSM2026-07-16
07630037847236APTUSMedartis AGFSM2026-07-16