Medtronic Reusable Instrument

GUDID 00643169405394

DISTRACTOR/TRIAL X0613952 3DEG 8X12X22

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00643169405394
• NIH Device Record Key: b0f375ad-8323-4bb5-9abf-e3723809f7fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medtronic Reusable Instrument
• Version Model Number: X0613952
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter
• Height: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169405394 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133650

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00643169405394]

Moist Heat or Steam Sterilization

[00643169405394]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-08-24

On-Brand Devices [Medtronic Reusable Instrument]

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