STAR

Basic Information

• Brand Name: STAR
• Primary DI: 00886385016504
• Version / Model: 400-259
• Company Name: Stryker Trauma SA
• Labeler DUNS: 481999654
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-27
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: cf766627-0f22-4702-86fa-dad17e9646d8

Device Description

Talar Component, Single Coated/US Version LARGE, LEFT

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
NTG	Prosthesis, Ankle, Uncemented, Non-Constrained	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
48181	Coated ankle talus prosthesis	A sterile implantable device designed to replace the proximal talus (talar component) as part of a primary ankle joint replacement or prosthesis revision. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00886385016504	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	35	Millimeter
Width	38	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid exposure to direct sunlight or dampness
• Type: Storage Environment Humidity
• Temperature Range: 50 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 18 – 20 Degrees Celsius