03402722

GUDID H679034027220

7MM BROACH/CURVED TIP FOR RADIAL HEAD PROSTHESIS

Synthes GmbH

Elbow radius prosthesis

• Primary Device ID: H679034027220
• NIH Device Record Key: 78254ead-b025-4de9-bea0-5e8c2084c8fc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 03.402.722
• Catalog Number: 03402722
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611819509269 [Direct Marking]
GS1	10886982080301 [Primary]
HIBCC	H679034027220 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112030

FDA Product Code

• KWI: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Sterilization

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

[H679034027220]

Moist Heat or Steam Sterilization

[H679034027220]

Moist Heat or Steam Sterilization

[H679034027220]

Moist Heat or Steam Sterilization

[H679034027220]

Moist Heat or Steam Sterilization

[H679034027220]

Moist Heat or Steam Sterilization

[H679034027220]

Moist Heat or Steam Sterilization

[H679034027220]

Moist Heat or Steam Sterilization

[H679034027220]

Moist Heat or Steam Sterilization

[H679034027220]

Moist Heat or Steam Sterilization

[H679034027220]

Moist Heat or Steam Sterilization

[H679034027220]

Moist Heat or Steam Sterilization

[H679034027220]

Moist Heat or Steam Sterilization

[H679034027220]

Moist Heat or Steam Sterilization

[H679034027220]

Moist Heat or Steam Sterilization

[H679034027220]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-04-28
• Device Publish Date: 2015-09-14

Devices Manufactured by Synthes GmbH

• 10886982350190 - NA: 2025-09-22 2.0MM STRAIGHT PLATE 20 HOLES
• 10887587078465 - NA: 2025-09-19 NONRETAINING SCREWDRIVER BLADE FOR 90DEG SCREWDRIVER
• 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