03402006

GUDID H679034020060

6MM STRAIGHT TRIAL RADIAL STEM 24MM

SYNTHES (U.S.A.) LP

Elbow radius prosthesis

• Primary Device ID: H679034020060
• NIH Device Record Key: 27606606-4c7d-4e45-89eb-7f6b0b9840f5
• Commercial Distribution Discontinuation: 2020-07-09
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 03.402.006
• Catalog Number: 03402006
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611819508705 [Direct Marking]
GS1	10886982079862 [Primary]
HIBCC	H679034020060 [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

[H679034020060]

Moist Heat or Steam Sterilization

[H679034020060]

Moist Heat or Steam Sterilization

[H679034020060]

Moist Heat or Steam Sterilization

[H679034020060]

Moist Heat or Steam Sterilization

[H679034020060]

Moist Heat or Steam Sterilization

[H679034020060]

Moist Heat or Steam Sterilization

[H679034020060]

Moist Heat or Steam Sterilization

[H679034020060]

Moist Heat or Steam Sterilization

[H679034020060]

Moist Heat or Steam Sterilization

[H679034020060]

Moist Heat or Steam Sterilization

[H679034020060]

Moist Heat or Steam Sterilization

[H679034020060]

Moist Heat or Steam Sterilization

[H679034020060]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-07-09
• Device Publish Date: 2015-09-14

Devices Manufactured by SYNTHES (U.S.A.) LP

• 10886982297280 - NA: 2024-09-11 SCHANZ PIN REMOVAL TOOL
• H9814871830 - Click'X: 2024-09-11 7.0MM TI CLICK'X® MONOAXIAL PEDICLE SCREW 90MM THRD LENGTH
• H9812982060 - NA: 2024-07-24 ANGLED LAMINA HOOK/ DUAL-OPENING SIDE
• H6792042280 - NA: 2024-07-24 3.5MM SHAFT SCREW 28MM
• H6792042320 - NA: 2024-07-24 3.5MM SHAFT SCREW 32MM
• H6792042340 - NA: 2024-07-24 3.5MM SHAFT SCREW 34MM
• H6792042360 - NA: 2024-07-24 3.5MM SHAFT SCREW 36MM
• H6792042380 - NA: 2024-07-24 3.5MM SHAFT SCREW 38MM