Medtronic Reusable Instruments

GUDID 00613994730169

RACK 9411605 16MM E

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic prosthesis implantation instrument, reusable
Primary Device ID00613994730169
NIH Device Record Keyac3bf3ca-075d-4464-94bc-81affae71ebf
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedtronic Reusable Instruments
Version Model Number9411605
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

Device Dimensions

Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter
Outer Diameter16 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994730169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00613994730169]

Moist Heat or Steam Sterilization

[00613994730169]

Moist Heat or Steam Sterilization

[00613994730169]

Moist Heat or Steam Sterilization

[00613994730169]

Moist Heat or Steam Sterilization

[00613994730169]

Moist Heat or Steam Sterilization

[00613994730169]

Moist Heat or Steam Sterilization

[00613994730169]

Moist Heat or Steam Sterilization

[00613994730169]

Moist Heat or Steam Sterilization

[00613994730169]

Moist Heat or Steam Sterilization

[00613994730169]

Moist Heat or Steam Sterilization

[00613994730169]

Moist Heat or Steam Sterilization

[00613994730169]

Moist Heat or Steam Sterilization

[00613994730169]

Moist Heat or Steam Sterilization

[00613994730169]

Moist Heat or Steam Sterilization

[00613994730169]

Moist Heat or Steam Sterilization

[00613994730169]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-09

On-Brand Devices [Medtronic Reusable Instruments]

00613994900999DISTRACTOR/TRIAL X1010843 6X26
00613994900982DISTRACTOR/TRIAL X1010842 6X22
00613994898500DISTRACTOR/TRIAL X09103461 12 X 8 X 22
00613994898494DISTRACTOR/TRIAL X09103462 12 X 8 X 26
00613994898487DISTRACTOR/TRIAL X09103463 12 X 8 X 32
00613994898470DISTRACTOR/TRIAL X09103464 12 X 8 X 36
00613994898463DISTRACTOR/TRIAL X09103465 12 X 10 X 22
00613994898456DISTRACTOR/TRIAL X09103466 12 X 10 X 26
00613994898449DISTRACTOR/TRIAL X09103467 12 X 10 X 32
00613994898432DISTRACTOR/TRIAL X09103468 12 X 10 X 36
00613994898425DISTRACTOR/TRIAL X09103469 12 X 12 X 22
00613994898418DISTRACTOR/TRIAL X09103470 12 X 12 X 26
00613994898401DISTRACTOR/TRIAL X09103471 12 X 12 X 32
00613994898395DISTRACTOR/TRIAL X09103472 12 X 12 X 36
00613994898388DISTRACTOR/TRIAL X09103473 12 X 14 X 22
00613994898371DISTRACTOR/TRIAL X09103474 12 X 14 X 26
00613994898364DISTRACTOR/TRIAL X09103475 12 X 14 X 32
00613994898357DISTRACTOR/TRIAL X09103476 12 X 14 X 36
00613994898340DISTRACTOR/TRIAL X09103477 12 X 16 X 22
00613994898333DISTRACTOR/TRIAL X09103478 12 X 16 X 26
00613994898326DISTRACTOR/TRIAL X09103479 12 X 16 X 32
00613994898319DISTRACTOR/TRIAL X09103480 12 X 16 X 36
00613994808257SCREW PFF0040 40MM FACET FIXATION ANCHOR
00613994808240SCREW PFF0035 35MM FACET FIXATION ANCHOR
00613994808233SCREW PFF0030 30MM FACET FIXATION ANCHOR
00613994808226SCREW PFF0025 25MM FACET FIXATION ANCHOR
00613994806291TRIAL 2981126 CAPSTONE 11 X 26MM
00613994806284TRIAL 2981122 CAPSTONE 11 X 22MM
00613994806277TRIAL 2980936 CAPSTONE 09 X 36MM
00613994806260TRIAL 2980932 CAPSTONE 09 X 32MM
00613994806253TRIAL 2980926 CAPSTONE 09 X 26MM
00613994806246TRIAL 2980922 CAPSTONE 09 X 22MM
00613994806239TRIAL 2980736 CAPSTONE 07 X 36MM
00613994806215TRIAL 2980726 CAPSTONE 07 X 26MM
00613994806208TRIAL 2980722 CAPSTONE 07 X 22MM
00613994806178TRIAL 2980626 CAPSTONE 06 X 26MM
00613994806161TRIAL 2980622 CAPSTONE 06 X 22MM
00613994806154TRIAL 2981636 CAPSTONE 16 X 36MM
00613994806147TRIAL 2981632 CAPSTONE 16 X 32MM
00613994806130TRIAL 2981626 CAPSTONE 16 X 26MM
00613994806123TRIAL 2981622 CAPSTONE 16 X 22MM
00613994806116TRIAL 2981536 CAPSTONE 15 X 36MM
00613994806109TRIAL 2981532 CAPSTONE 15 X 32MM
00613994806093TRIAL 2981526 CAPSTONE 15 X 26MM
00613994806086TRIAL 2981522 CAPSTONE 15 X 22MM
00613994806079TRIAL 2981336 CAPSTONE 13 X 36MM
00613994806062TRIAL 2981332 CAPSTONE 13 X 32MM
00613994806055TRIAL 2981326 CAPSTONE 13 X 26MM
00613994806048TRIAL 2981322 CAPSTONE 13 X 22MM
00613994806031TRIAL 2981136 CAPSTONE 11 X 36MM
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