04206232

GUDID H679042062320

3.5MM TI CRTX SCR/LOW PROF HD SELF-TAPPING/STARDRIVE/32MM

Synthes GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: H679042062320
• NIH Device Record Key: d7aa5871-af6c-4202-b8e0-76178c740fe6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 04.206.232
• Catalog Number: 04206232
• 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	10886982117649 [Primary]
HIBCC	H679042062320 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111230

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

Moist Heat or Steam Sterilization

[H679042062320]

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

Devices Manufactured by Synthes GmbH

• 10886982348982 - NA: 2025-07-24 Ø12.8MM HOLLOW REAMER
• 10886982349835 - NA: 2025-07-24 WRENCH / 11MM SLOTTED SOCKET
• 10886982350121 - NA: 2025-07-24 FEMORAL GONIOMETER
• 10886982350152 - NA: 2025-07-24 5TH MET WIRE GUIDE
• 10886982350428 - NA: 2025-07-24 TENS BENDING EXTRACTOR
• 10886982348326 - NA: 2025-07-08 SCREW RACK 3.0 & 4.0
• 10887587078434 - NA: 2025-07-03 REDUCTION FORCEPS W/ POINTS
• 10886982343994 - NA: 2025-07-01 Ø14MM HOLLOW REAMER - FRN