Ascension MCP Joint Replacement

Basic Information

• Brand Name: Ascension MCP Joint Replacement
• Primary DI: 00885556856765
• Version / Model: MCP-100-30P-WW
• Catalog Number: MCP-100-30P-WW
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-22
• Public Version: 3
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: bb35cdb0-4e56-4f3f-b380-5c7c4263e105

Device Description

MCP SZ. 30 PROXIMAL WW

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NEG	Finger semi-constrained pyrolytic carbon uncemented prosthesis	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61852	Metacarpophalangeal joint prosthesis, modular	A implantable artificial substitute for the metacarpophalangeal (MCP) joint(s) of the hand (finger) which typically has been damaged by rheumatoid, degenerative, or traumatic arthritis. It consists of multiple components made of metal [e.g., cobalt-chrome (Co-Cr)] and/or plastic (e.g., polyethylene) with stems and articulating surfaces. Dedicated tools for implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885556856765	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P000057	007