BIOARCH

Basic Information

• Brand Name: BIOARCH
• Primary DI: 00840420128928
• Version / Model: ST1112
• Catalog Number: ST1112
• Company Name: WRIGHT MEDICAL TECHNOLOGY, INC.
• Labeler DUNS: 807201207
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-01
• Public Version: 5
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 1f48bf84-2d1d-4c97-b35f-eeda738d12f8

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HWC	Screw, fixation, bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40352	Subtalar implant, non-bioabsorbable	A device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840420128928	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	12	Millimeter
Device Size Text, specify			Size: 12mm