Ascension® Modular Radial Head MRH-350-01-WW

GUDID 10381780114437

Ascension® Modular Radial Head Radial Implant Stem

Ascension Orthopedics, Inc.

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• Primary Device ID: 10381780114437
• NIH Device Record Key: 04550297-a202-422e-ac3b-ca1a111f3dcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ascension® Modular Radial Head
• Version Model Number: MRH35001
• Catalog Number: MRH-350-01-WW
• Company DUNS: 942377524
• Company Name: Ascension Orthopedics, Inc.
• 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: true
• 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)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780114437 [Primary]
HIBCC	M269MRH35001WW1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032686

FDA Product Code

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

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-08-27
• Device Publish Date: 2017-10-09

On-Brand Devices [Ascension® Modular Radial Head]

• 10381780114529: Ascension® Modular Radial Head Radial Implant Head
• 10381780114512: Ascension® Modular Radial Head Radial Implant Head
• 10381780114505: Ascension® Modular Radial Head Radial Implant Head
• 10381780114499: Ascension® Modular Radial Head Radial Implant Head
• 10381780114482: Ascension® Modular Radial Head Radial Implant Head
• 10381780114475: Ascension® Modular Radial Head Radial Implant Head
• 10381780114468: Ascension® Modular Radial Head Radial Implant Stem
• 10381780114451: Ascension® Modular Radial Head Radial Implant Stem
• 10381780114444: Ascension® Modular Radial Head Radial Implant Stem
• 10381780114437: Ascension® Modular Radial Head Radial Implant Stem