IB3D™ PL Spinal System

GUDID 00763000883492

TRAY A24100100 IB3D PL TRAY

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray, reusable
Primary Device ID00763000883492
NIH Device Record Keyc2217b45-478f-4f8b-8b09-5bad2f97db48
Commercial Distribution StatusIn Commercial Distribution
Brand NameIB3D™ PL Spinal System
Version Model NumberA24100100
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 Latexfalse
RX Perscriptionfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000883492 [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

[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


[00763000883492]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-08
Device Publish Date2025-03-31

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00763000273804 - n/a2025-10-06 SCREWDRIVER 3606201 TORQUE LIMIT SHAFT
00763000875282 - SHILLA™ Growth Guidance System2025-10-06 SCREW 7675430 5.5 SHILLA MAS CANN 4.5X30
00763000884956 - n/a2025-10-06 LOCK SCREW DRIVER 7080930 TRI-FLAT
00885074240695 - n/a2025-09-30 ACCESSORIES 3299003 GRAFT TAMP
00199150026029 - Medtronic Reusable Instruments2025-09-29 COMPRESSOR X0525001 RACK AND PINION
00763000684044 - Medtronic Reusable Instruments2025-09-29 INSTRUMENT 950-146 RULER
00763000856700 - VERTE-STACK® Spinal System2025-09-29 STRUT 6242064 ANATOMIC 16X14X24MM
00763000879563 - ENDOSKELETON® TCS2025-09-29 HANDLE 5210-1016 TCS RATCHETING HANDLE

Trademark Results [IB3D]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IB3D
IB3D
98258478 not registered Live/Pending
Medicrea International
2023-11-07

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