03311310

GUDID H679033113100

TI HALF RING/100MM DIAMETER

Synthes GmbH

External orthopaedic fixation system reprocessed component

• Primary Device ID: H679033113100
• NIH Device Record Key: 5a7b5158-7dd6-4e86-98e9-d86d353ecd23
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 03.311.310
• Catalog Number: 03311310
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982078575 [Primary]
HIBCC	H679033113100 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051600

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[H679033113100]

Moist Heat or Steam Sterilization

[H679033113100]

Moist Heat or Steam Sterilization

[H679033113100]

Moist Heat or Steam Sterilization

[H679033113100]

Moist Heat or Steam Sterilization

[H679033113100]

Moist Heat or Steam Sterilization

[H679033113100]

Moist Heat or Steam Sterilization

[H679033113100]

Moist Heat or Steam Sterilization

[H679033113100]

Moist Heat or Steam Sterilization

[H679033113100]

Moist Heat or Steam Sterilization

[H679033113100]

Moist Heat or Steam Sterilization

[H679033113100]

Moist Heat or Steam Sterilization

[H679033113100]

Moist Heat or Steam Sterilization

[H679033113100]

Moist Heat or Steam Sterilization

[H679033113100]

Moist Heat or Steam Sterilization

[H679033113100]

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

• 10886982349873 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 16MM
• 10886982349880 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 18MM
• 10886982349897 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 20MM
• 10886982349903 - NA: 2025-09-01 CANNULATED CIRCULAR REAMER 22MM
• 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