FDA.report

n/a

Primary DI
00643169404946
Brand
n/a
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
7068060
Device description
TRAY 7068060 IMPLANT INSTRUMENT 5.5/6.0
Published
2017-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications

CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00643169404946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169404946006431694049466431694049460643169404946

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags

DUNS number
830350380
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00199150015429CD HORIZON® Spinal System593290202026-03-21
00199150015436CD HORIZON® Spinal System593290212026-03-21
00199150024469INFINITY™ Occipitocervical Upper Thoracic SystemNAV36500052026-03-22
00199150024483INFINITY™ Occipitocervical Upper Thoracic SystemNAV36062002026-03-22
00199150038138INFINITY™ Occipitocervical Upper Thoracic SystemNAV36500302026-03-21
00199150039524n/a36500042026-03-22
00199150044016Medtronic Reusable Instruments and Accessories65500252026-03-22
00199150051212Medtronic Reusable Instruments and AccessoriesRBT0901012026-03-22
00199150062263Medtronic Reusable InstrumentsEX10122552026-03-20
00199150062270Medtronic Reusable InstrumentsEX10122752026-03-20
00199150062287Medtronic Reusable InstrumentsEX10122902026-03-20
00199150066872Medtronic Reusable InstrumentsEX11250062026-03-20
00199150067343Medtronic Reusable InstrumentsEX12250162026-03-22
00199150067459Medtronic Reusable InstrumentsEX12250172026-03-20
00199150069675Medtronic Reusable InstrumentsX01260012026-03-20
00763000710194Medtronic Reusable Instruments and Accessories65520282026-03-22
00763000869069CD HORIZON® Spinal System593290142026-03-21
00763000869076CD HORIZON® Spinal System593290152026-03-21
00763000869090CD HORIZON® Spinal System593290172026-03-21
00763000869106CD HORIZON® Spinal System593290182026-03-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00763000887131CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887162CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887179CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
088000333582064CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2020-03-26
088000333846944CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847174CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847244CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847484CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847554CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847624CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847794CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847864CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333850974CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-12-11
088000333851104CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-12-11
088000333859984CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860184CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860494CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860564CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860634CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860704CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860874CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860944CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861004CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861174CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861244CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861314CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861484CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861624CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861794CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861864CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24