T2 1846-1548S

GUDID 07613153319016

Reconstruction Nail R2.0, Ti, LEFT

Stryker Trauma GmbH

Femur nail, sterile

• Primary Device ID: 07613153319016
• NIH Device Record Key: 3daf9668-c15e-41b1-b9c9-5ca765423c42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T2
• Version Model Number: 1846-1548S
• Catalog Number: 1846-1548S
• Company DUNS: 330211587
• Company Name: Stryker Trauma GmbH
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter
• Device Size Text, specify: 0
• Angle: 125 degree
• Length: 480 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613153319016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032898

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [T2]

• 07613327005523: Fixation K-Wire SPI, WCH coated
• 07613327005516: Plug SPI
• 07613327005486: Trocar SPI ¿8-11
• 07613327005479: Tray Inlay SPI
• 07613327005462: Modular Handle SPI
• 07613327005431: Drill Sleeve SPI ¿8-13, PTFE coated
• 07613327005424: Drill Sleeve SPI ¿8-11, PTFE coated
• 07613327005417: Nail Insertion Sleeve, elastic SPI ¿8-13
• 07613327005400: Screwdriver, Compression SPI Hex 3,5mm
• 07613327005394: Nail Holding Screw SPI
• 07613327005387: Nail Adapter SPI
• 07613327005370: Opening Drill SPI
• 07613327003949: Trocar SPI ¿8-13
• 07613252630425: Tray Inlay SPI
• 07613252577478: Fixation K-Wire SPI, WCH coated
• 07613252212225: Reconstruction Nail R2.0, Ti, RIGHT
• 07613252212218: Reconstruction Nail R2.0, Ti, RIGHT
• 07613252212201: Reconstruction Nail R2.0, Ti, RIGHT
• 07613252212195: Reconstruction Nail R2.0, Ti, RIGHT
• 07613252212188: Reconstruction Nail R2.0, Ti, RIGHT
• 07613252212171: Reconstruction Nail R2.0, Ti, RIGHT
• 07613252133247: Femoral Nail, RIGHT
• 07613252133230: Femoral Nail, RIGHT
• 07613252133223: Femoral Nail, RIGHT
• 07613252133209: Femoral Nail, RIGHT
• 07613252133117: Femoral Nail, RIGHT
• 07613252133100: Femoral Nail, RIGHT
• 07613252133094: Femoral Nail, RIGHT
• 07613252133087: Femoral Nail, RIGHT
• 07613252132998: Femoral Nail, RIGHT
• 07613252132974: Femoral Nail, RIGHT
• 07613252132967: Femoral Nail, RIGHT
• 07613252132950: Femoral Nail, RIGHT
• 07613252132851: Femoral Nail, RIGHT
• 07613252132844: Femoral Nail, RIGHT
• 07613252132837: Femoral Nail, RIGHT
• 07613252132820: Femoral Nail, RIGHT
• 07613252132721: Femoral Nail, RIGHT
• 07613252132714: Femoral Nail, RIGHT
• 07613252132707: Femoral Nail, RIGHT
• 07613252132684: Femoral Nail, RIGHT
• 07613252132592: Femoral Nail, RIGHT
• 07613252132585: Femoral Nail, RIGHT
• 07613252132578: Femoral Nail, RIGHT
• 07613252132554: Femoral Nail, RIGHT
• 07613252132493: Femoral Nail, RIGHT
• 07613252132479: Femoral Nail, RIGHT
• 07613252132356: Femoral Nail, LEFT
• 07613252132349: Femoral Nail, LEFT
• 07613252132332: Femoral Nail, LEFT