GUDID 00763000152673

TRAY 7068026 OPEN

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray
Primary Device ID00763000152673
NIH Device Record Keyfe450eeb-d4c5-473c-b8fb-cd70473d2447
Commercial Distribution StatusIn Commercial Distribution
Version Model Number7068026
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000152673 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization wrap containers, trays, cassettes & other accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


[00763000152673]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-14
Device Publish Date2020-02-06

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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00199150000722 - Medtronic Reusable Instruments2025-06-30 TRIAL X06180855 8MM X 55MM DL MODULAR
00199150000739 - Medtronic Reusable Instruments2025-06-30 TRIAL X06181045 10MM X 45MM DL MODULAR
00199150000746 - Medtronic Reusable Instruments2025-06-30 TRIAL X06181050 10MM X 50MM DL MODULAR
00199150000753 - Medtronic Reusable Instruments2025-06-30 TRIAL X06181055 10MM X 55MM DL MODULAR
00199150000760 - Medtronic Reusable Instruments2025-06-30 TRIAL X06181245 12MM X 45MM DL MODULAR
00199150000777 - Medtronic Reusable Instruments2025-06-30 TRIAL X06181250 12MM X 50MM DL MODULAR

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