N/A

GUDID 00613994894946

SPECULUM X0810493 50MM

MEDTRONIC SOFAMOR DANEK, INC.

Self-retaining surgical retractor, reusable
Primary Device ID00613994894946
NIH Device Record Key8e8842db-41c0-4e68-b03a-311a3371d8d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberX0810493
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994894946 [Primary]

FDA Product Code

LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00613994894946]

Moist Heat or Steam Sterilization

[00613994894946]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-12-16

On-Brand Devices [N/A]

00613994949042TRAY 7069005 DUAL LEAD TAP
00613994946720ROCKER 5484333 ROCKER EXTENDED
00613994946706LID 7068567 CANN MAS XTRA 5.5-8.5 LID
00613994946690MODULE 7068566 CANN MAS XTRA 5.5-8.5 MOD
00613994946683LID 7068565 CANN MAS EXTRA 7.5 MOD LID
00613994946676MODULE 7068564 CANN MAS EXTRA 7.5 MOD
00613994946652DRIVER 5484339 DUAL PURPOSE DRIVER
00613994946638PROTECTOR 2942058 18MM ENDPLATE
00613994946614STARTER 5484338 NON-BREAKOFF PLUG
00613994946607DRIVER 5484337 NON-BRKOFF PROVSNL INSERT
00613994946591DRIVER 5484336 RMAS BREAKOFF
00613994946515IMPLANT HOLDER EX0111192 5.5 STRAIGHT
00613994944931ROD GRIPPER X0111149 90 DEGREE
00613994937841MODIFIED X0110242 FLEX ARM
00613994922274IMPLANT HOLDER EX1210012 6.35 STRAIGHT
00613994922182REDUCER EX0810522 MICRO
00613994912046INSTRUMENT 7570946 SCREW GHOST
00613994912039INSTRUMENT 7570945 FLUOROSCOPIC RULER
00613994912022INSTRUMENT 7570944 EXTENDER COLLAR
00613994912015INSTRUMENT 7570942 FRACTURE REDUCER
00613994912008INSTRUMENT 7570940 COMPRESSOR DISTRACTOR
006139949098179.5 TAP X1010056 CANNULATED DUAL THREAD
006139949098009.0 TAP X1010055 CANNULATED DUAL THREAD
006139949097948.5 TAP X1010022 CANNULATED DUAL THREAD
00613994905758ADAPTER 2346051 POWEREASE HANDLE ADAPTER
00613994905741ADAPTER 2346050 POWEREASE SQUARE ADAPTER
00613994904850GUIDEWIRE X1110004 BLUNT
00613994901170TRAY 1207788 PREVAIL
00613994901163HOLDER 5484391 4.75 VCM IMPLANT HOLDER
00613994901057RETRACTOR X0810464 RACK WORM GEAR
00613994898043TRAY 6660010 STND TRIAL LOWER
00613994896384CRIMP X1010599 MINI REDUCTION
00613994896377REMOVAL TOOL X1010604 MINI CRIMP
00613994894953SPECULUM X0810494 70MM
00613994894946SPECULUM X0810493 50MM
00613994894939SPECULUM X0810492 30MM
00613994894779DRILL X1010147 2.4MM BIT
00613994894755TAP X09103869 CANNULATED 4.5
00613994894748TAP X09103870 CANNULATED 5.0
00613994894731TAP X09103871 CANNULATED 5.5
00613994894724TAP X09103872 CANNULATED 6.0
00613994894717TAP X09103873 CANNULATED 6.5
00613994894700TAP X09103874 CANNULATED 7.0
00613994894694TAP X09103875 CANNULATED 7.5
00613994894687TAP X09103876 CANNULATED 8.0
00613994894670TAP X09103877 CANNULATED 8.5
00613994894663TAP X09103878 CANNULATED 9.0
00613994894656TAP X09103879 CANNULATED 9.5
00613994888372TRAY 9396009 INSTTRAY3
00613994884657PIN X09103370 PLATE HOLDING EXTENDED
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