SOFT LINE FULL INSOLE MD

Basic Information

• Brand Name: SOFT LINE FULL INSOLE MD
• Primary DI: 00610570086726
• Version / Model: 08140853
• Company Name: Bird & Cronin, LLC
• Labeler DUNS: 045975349
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-30
• Public Version: 1
• Public Version Date: 2022-09-07
• Public Version Status: New
• Public Device Record Key: 8e84d29d-7429-43f7-8399-0b8b1b1367b7

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNP	Orthosis, Corrective Shoe	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41435	Foot orthosis	A device designed to encompass the whole or part of the foot, or designed as a plantar insert, and intended to provide rigid or semi-rigid correction of the foot for persons with orthopaedic deformities/injuries of the feet; it may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds. It is typically made of metal, synthetic, and/or textile materials and may include customizable plantar inserts. This is a single-patient use device that can be reapplied to the patient during the treatment period (reusable) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00610570086726	GS1