03402719

GUDID H679034027190

9MM BROACH/STRAIGHT TIP FOR RADIAL HEAD PROSTHESIS

Synthes GmbH

Elbow radius prosthesis

• Primary Device ID: H679034027190
• NIH Device Record Key: 7806b56c-0604-4b2d-9826-8a903b478f53
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 03.402.719
• Catalog Number: 03402719
• 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	07611819509238 [Direct Marking]
GS1	10886982080271 [Primary]
HIBCC	H679034027190 [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

[H679034027190]

Moist Heat or Steam Sterilization

[H679034027190]

Moist Heat or Steam Sterilization

[H679034027190]

Moist Heat or Steam Sterilization

[H679034027190]

Moist Heat or Steam Sterilization

[H679034027190]

Moist Heat or Steam Sterilization

[H679034027190]

Moist Heat or Steam Sterilization

[H679034027190]

Moist Heat or Steam Sterilization

[H679034027190]

Moist Heat or Steam Sterilization

[H679034027190]

Moist Heat or Steam Sterilization

[H679034027190]

Moist Heat or Steam Sterilization

[H679034027190]

Moist Heat or Steam Sterilization

[H679034027190]

Moist Heat or Steam Sterilization

[H679034027190]

Moist Heat or Steam Sterilization

[H679034027190]

Moist Heat or Steam Sterilization

[H679034027190]

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

• 10886982347565 - NA: 2024-09-16 4.5 DRILL GUIDE
• 10886982346902 - NA: 2024-09-09 GUIDE WIRE Ø0.8 LENGTH 100MM DOUBLE TIP
• 10886982346919 - NA: 2024-09-09 GUIDE WIRE Ø1.1 LENGTH 150MM DOUBLE TIP
• 10886982346926 - NA: 2024-09-09 GUIDE WIRE Ø1.4 LENGTH 150MM DOUBLE TIP
• 10887587077055 - NA: 2024-08-29 MATRIXSTERNUM STRAIGHT PLATE 4 HOLES
• 10887587077062 - NA: 2024-08-29 MATRIXSTERNUM STRAIGHT PLATE 6 HOLES
• 10887587077079 - NA: 2024-08-29 MATRIXSTERNUM T-PLATE 7 HOLES
• 10887587077086 - NA: 2024-08-29 MATRIXSTERNUM X-PLATE SMALL/8 HOLES