SHILLA™ Growth Guidance System

GUDID 00613994798268

TRAY 7679061 5.5 INST 2

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray, reusable
Primary Device ID00613994798268
NIH Device Record Keycdb3d3e4-c4a2-4fb0-83e1-1074cb7c10f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSHILLA™ Growth Guidance System
Version Model Number7679061
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 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
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
GS100613994798268 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FSMTRAY, SURGICAL, INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


[00613994798268]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-12
Device Publish Date2021-03-04

On-Brand Devices [SHILLA™ Growth Guidance System]

00643169009943TRAY 7679029 4.5 MAS
00643169009929TRAY 7679027 4.5 FAS
00613994801333LID 7679021 SHILLA 4.5 SCRW CADDY CS2
00613994800008TRAY 7679001 SHLA 4.5 INSTR 1 CS 3
00613994799999TRAY 7679002 SHLA 4.5 INSTR 2 CS 3
00613994799975TRAY 7679004 SHLA 4.5 INSTR 1 CS 4
00613994799968TRAY 7679005 SHLA 4.5 INSTR 2 CS 4
00613994799944TRAY 7679007 SHLA 4.5 INSTR 1 CS 5
00613994799937TRAY 7679008 SHLA 4.5 INSTR 2 CS 5
00613994799920TRAY 7679009 SHLA 4.5 INSTR 3 CS 5
00613994799906TRAY 7679011 SHLA 4.5 XLINK INST
00613994799876TRAY 7679014 SHLA 4.5 FAS 1CS 1
00613994799852TRAY 7679016 SHLA 4.5 MAS 2 CS 2
00613994799845TRAY 7679017 SHLA 4.5 MAS 1 CS 2
00613994799838CADDY 7679018 SHILLA 4.5 XLINK CDY CS 2
00613994799821LID 7679019 SHLA 4.5 XLINK CDY CS 2
00613994799814CADDY 7679020 SHLA 4.5 ST SCRW CS 2
00613994798367TRAY 7679051 5.5 FAS 1
00613994798343TRAY 7679053 5.5 MAS 2
00613994798336TRAY 7679054 5.5 MAS 1
00613994798329CADDY 7679055 1 SHILLA 5.5 CROSSLINK
00613994798299CADDY LID 7679058 5.5 SET SCREW
00613994798275TRAY 7679060 5.5 INST 1
00613994798268TRAY 7679061 5.5 INST 2
00613994798244TRAY 7679063 5.5 INST 1
00613994798237TRAY 7679064 5.5 INST 2
00613994798213TRAY 7679066 5.5 INST 1
00613994798206TRAY 7679067 5.5 INST 2
00613994798190TRAY 7679068 5.5 INST 3
00613994798176TRAY 7679070 5.5 XLINK INST 1
00613994798312LID 7679056 5.5 XLINK CDY
00613994798305CADDY 7679057 5.5 SET SCREW
00613994803160SCREWDRIVER 7674444 4.5 CANNULATED MAS

Trademark Results [SHILLA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SHILLA
SHILLA
86036343 4720930 Live/Registered
Warsaw Orthopedic, Inc.
2013-08-13
SHILLA
SHILLA
85382974 4121295 Dead/Cancelled
INTERTEX & CO PTY LTD
2011-07-27
SHILLA
SHILLA
77968663 not registered Dead/Abandoned
Warsaw Orthopedic, Inc.
2010-03-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.