PyroSphere CMC

Basic Information

• Brand Name: PyroSphere CMC
• Primary DI: 00885556830888
• Version / Model: TRL-435-50
• Catalog Number: TRL-435-50
• 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: 2
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 12107b79-2e9b-4020-8da4-ab5ff24ca067

Device Description

PYROSPHERE TRIAL SZ. 50

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYI	Prosthesis, wrist, carpal trapezium	Orthopedic	888.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61047	Carpometacarpal interpositional spacer prosthesis trial	A sterile copy of a final carpometacarpal interpositional spacer prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, and to ensure its proper orientation and positioning. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885556830888	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042690	000