LUNATE TRIAL SZ. 01
PyroCarbon Lunate - TRL-715-01T
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- Moist Heat or Steam Sterilization
Product Codes
Code: KWN
Device Name: Prosthesis, Wrist, Carpal Lunate
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: OR
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 888.3750
Third Party Flag: N
Medical Specialty: OR
Device IdentifiersDevice Id: 00885556858820
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A