04130115

GUDID H679041301150

1.3MM TI LCKNG SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 15MM

Synthes GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: H679041301150
• NIH Device Record Key: 1dddbc8e-e23b-4d66-b7ee-a3d10b4b5f58
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 04.130.115
• Catalog Number: 04130115
• Company DUNS: 486711679
• Company Name: Synthes 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982112460 [Primary]
HIBCC	H679041301150 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150099

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

[H679041301150]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-29
• Device Publish Date: 2015-09-14

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