Ascension MCP MCP-100-20P-WW

GUDID M269MCP10020PWW1

Metacarpal-Phalangeal Joint Replacement Device

Ascension Orthopedics, Inc.

Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece Metacarpophalangeal joint prosthesis, one-piece

• Primary Device ID: M269MCP10020PWW1
• NIH Device Record Key: 072510bf-4869-4c2a-b626-57dd2de94619
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ascension MCP
• Version Model Number: MCP-100-20P-WW
• Catalog Number: MCP-100-20P-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
• 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
• 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
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780000396 [Primary]
HIBCC	M269MCP10020PWW1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000057

FDA Product Code

• NEG: Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis

Sterilization

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

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

[M269MCP10020PWW1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-07
• Device Publish Date: 2014-09-18

On-Brand Devices [Ascension MCP]

• M269MCP10050PWW1: Metacarpal-Phalangeal Joint Replacement Device
• M269MCP10050DWW1: Metacarpal-Phalangeal Joint Replacement Device
• M269MCP10040PWW1: Metacarpal-Phalangeal Joint Replacement Device
• M269MCP10040DWW1: Metacarpal-Phalangeal Joint Replacement Device
• M269MCP10030PWW1: Metacarpal-Phalangeal Joint Replacement Device
• M269MCP10030DWW1: Metacarpal-Phalangeal Joint Replacement Device
• M269MCP10020PWW1: Metacarpal-Phalangeal Joint Replacement Device
• M269MCP10020DWW1: Metacarpal-Phalangeal Joint Replacement Device
• M269MCP10010PWW1: Metacarpal-Phalangeal Joint Replacement Device
• M269MCP10010DWW1: Metacarpal-Phalangeal Joint Replacement Device
• M269MCP11005PWW1: Metacarpal-Phalangeal Joint Replacement Device
• M269MCP11005DWW1: Metacarpal-Phalangeal Joint Replacement Device