Medtronic Reusable Instrument

GUDID 00643169405448

DISTRACTOR/TRIAL X0613957 6DEG 8X9X26

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage
Primary Device ID00643169405448
NIH Device Record Key6e3ddc87-026e-4feb-bda3-00a5509352bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedtronic Reusable Instrument
Version Model NumberX0613957
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

Device Dimensions

Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter
Length26 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169405448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169405448]

Moist Heat or Steam Sterilization

[00643169405448]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2015-08-21

On-Brand Devices [Medtronic Reusable Instrument]

00643169405561DISTRACTOR/TRIAL X0613969 9DEG 8X10X26
00643169405554DISTRACTOR/TRIAL X0613968 9DEG 8X10X22
00643169405547DISTRACTOR/TRIAL X0613967 9DEG 8X9X26
00643169405530DISTRACTOR/TRIAL X0613966 9DEG 8X9X22
00643169405523DISTRACTOR/TRIAL X0613965 9DEG 8X8X26
00643169405516DISTRACTOR/TRIAL X0613964 9DEG 8X8X22
00643169405509DISTRACTOR/TRIAL X0613963 6DEG 8X12X26
00643169405493DISTRACTOR/TRIAL X0613962 6DEG 8X12X22
00643169405486DISTRACTOR/TRIAL X0613961 6DEG 8X11X26
00643169405479DISTRACTOR/TRIAL X0613960 6DEG 8X11X22
00643169405462DISTRACTOR/TRIAL X0613959 6DEG 8X10X26
00643169405455DISTRACTOR/TRIAL X0613958 6DEG 8X10X22
00643169405448DISTRACTOR/TRIAL X0613957 6DEG 8X9X26
00643169405431DISTRACTOR/TRIAL X0613956 6DEG 8X9X22
00643169405424DISTRACTOR/TRIAL X0613955 6DEG 8X8X26
00643169405417DISTRACTOR/TRIAL X0613954 6DEG 8X8X22
00643169405400DISTRACTOR/TRIAL X0613953 3DEG 8X12X26
00643169405394DISTRACTOR/TRIAL X0613952 3DEG 8X12X22
00643169405387DISTRACTOR/TRIAL X0613951 3DEG 8X11X26
00643169405370DISTRACTOR/TRIAL X0613950 3DEG 8X11X22
00643169405363DISTRACTOR/TRIAL X0613949 3DEG 8X10X26
00643169405356DISTRACTOR/TRIAL X0613948 3DEG 8X10X22
00643169405349DISTRACTOR/TRIAL X0613947 3DEG 8X9X26
00643169405332DISTRACTOR/TRIAL X0613946 3DEG 8X9X22
00643169405325DISTRACTOR/TRIAL X0613945 3DEG 8X8X26
00643169405318DISTRACTOR/TRIAL X0613944 3DEG 8X8X22
00643169405301DISTRACTOR/TRIAL X06131003 9DEG 10X12X26
00643169405295DISTRACTOR/TRIAL X06131002 9DEG 10X12X22
00643169405288DISTRACTOR/TRIAL X06131001 9DEG 10X11X26
00643169405271DISTRACTOR/TRIAL X06131000 9DEG 10X11X22
00643169405264DISTRACTOR/TRIAL X0613999 9DEG 10X10X26
00643169405240DISTRACTOR/TRIAL X0613997 9DEG 10X9X26
00643169405233DISTRACTOR/TRIAL X0613996 9DEG 10X9X22
00643169405226DISTRACTOR/TRIAL X0613995 9DEG 10X8X26
00643169405219DISTRACTOR/TRIAL X0613994 9DEG 10X8X22
00643169405202DISTRACTOR/TRIAL X0613993 6DEG 10X12X26
00643169405196DISTRACTOR/TRIAL X0613992 6DEG 10X12X22
00643169405189DISTRACTOR/TRIAL X0613991 6DEG 10X11X26
00643169405172DISTRACTOR/TRIAL X0613990 6DEG 10X11X22
00643169405165DISTRACTOR/TRIAL X0613989 6DEG 10X10X26
00643169405158DISTRACTOR/TRIAL X0613988 6DEG 10X10X22
00643169405141DISTRACTOR/TRIAL X0613987 6DEG 10X9X26
00643169405134DISTRACTOR/TRIAL X0613986 6DEG 10X9X22
00643169405127DISTRACTOR/TRIAL X0613985 6DEG 10X8X26
00643169405110DISTRACTOR/TRIAL X0613984 6DEG 10X8X22
00643169405103DISTRACTOR/TRIAL X0613983 3DEG 10X12X26
00643169405097DISTRACTOR/TRIAL X0613982 3DEG 10X12X22
00643169405080DISTRACTOR/TRIAL X0613981 3DEG 10X11X26
00643169405073DISTRACTOR/TRIAL X0613980 3DEG 10X11X22
00643169405066DISTRACTOR/TRIAL X0613979 3DEG 10X10X26
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