Ascension® Silicone MCP SMCP50005WW

GUDID 10381780114376

The Ascension® Silicone MCP is an anatomically designed, one-piece, flexible hinge prosthesis designed to be implanted without bone cement across the metacarpophalangeal joint. It is made from medical grade silicone elastomer. The proximal and distal stems of the Ascension® Silicone MCP are pre-flexed at 30º to match the approximate natural 30º flexion stance of the relaxed human hand. The Ascension® Silicone MCP is intended for cementless replacement of the metacarpophalangeal (MCP) joint of the finger where disabled by rheumatoid, degenerative, or traumatic arthritis.

Ascension Orthopedics, Inc.

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• Primary Device ID: 10381780114376
• NIH Device Record Key: 2fa0bde3-517c-44d5-847c-c7fca39ec160
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ascension® Silicone MCP
• Version Model Number: SMCP50005WW
• Catalog Number: SMCP50005WW
• 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
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• Email: custsvcnj@integralife.com
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• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
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• Email: custsvcnj@integralife.com
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• 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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780114376 [Primary]
HIBCC	M268SMCP50005WW1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022892

FDA Product Code

• KYJ: PROSTHESIS, FINGER, CONSTRAINED, 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: 2019-10-07
• Device Publish Date: 2017-10-09

On-Brand Devices [Ascension® Silicone MCP]

• 10381780114383: The Ascension® Silicone MCP is an anatomically designed, one-piece, flexible hinge prosthesis d
• 10381780114420: The Ascension® Silicone MCP is an anatomically designed, one-piece, flexible hinge prosthesis d
• 10381780114413: The Ascension® Silicone MCP is an anatomically designed, one-piece, flexible hinge prosthesis d
• 10381780114406: The Ascension® Silicone MCP is an anatomically designed, one-piece, flexible hinge prosthesis d
• 10381780114390: The Ascension® Silicone MCP is an anatomically designed, one-piece, flexible hinge prosthesis d
• 10381780114376: The Ascension® Silicone MCP is an anatomically designed, one-piece, flexible hinge prosthesis d