02206016

GUDID H679022060160

3.5MM CRTX SCREW/LOW PROF HD SELF-TAPPING/HEX DRIVE/16MM

Synthes GmbH

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: H679022060160
• NIH Device Record Key: d1018501-e50e-4644-9bc5-26d6b2f15478
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 02.206.016
• Catalog Number: 02206016
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982050106 [Primary]
HIBCC	H679022060160 [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

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

[H679022060160]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-28
• Device Publish Date: 2015-09-14

Devices Manufactured by Synthes GmbH

• 10886982350039 - NA: 2025-08-15 CRE DRILL GUIDE 15MM
• 10886982350046 - NA: 2025-08-15 CRE DRILL GUIDE 18MM
• 10886982350053 - NA: 2025-08-15 CRE DRILL GUIDE 20MM
• 10886982350060 - NA: 2025-08-15 CRE DRILL GUIDE 25MM
• 10886982350077 - NA: 2025-08-15 7.0MM CAN TAP LARGE QUICK COUPLING
• 07612334226747 - NA: 2025-07-31 LID 2/3 SIZE STAINLESS STEEL
• 07612334227980 - NA: 2025-07-31 TRAY FOR OPERACE, 1 FROM 2
• 07612334228352 - NA: 2025-07-31 TRAY FOR OPERACE, 2 FROM 2