EXPert 03010488

GUDID H679030104880

RADIOLUCENT INSERTION HANDLE FOR EXPERT ALFN/100MM

SYNTHES (U.S.A.) LP

Orthopaedic implant/trial-implant/sizer holder, reusable

• Primary Device ID: H679030104880
• NIH Device Record Key: 509a6791-4bd8-45a1-b55f-97c34675a58a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPert
• Version Model Number: 03.010.488
• Catalog Number: 03010488
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611819498877 [Direct Marking]
GS1	10886982069061 [Primary]
HIBCC	H679030104880 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070843

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

[H679030104880]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-06
• Device Publish Date: 2015-09-14

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• H6792042320 - NA: 2024-07-24 3.5MM SHAFT SCREW 32MM
• H6792042340 - NA: 2024-07-24 3.5MM SHAFT SCREW 34MM
• H6792042360 - NA: 2024-07-24 3.5MM SHAFT SCREW 36MM
• H6792042380 - NA: 2024-07-24 3.5MM SHAFT SCREW 38MM