APOS 4

Basic Information

• Brand Name: APOS 4
• Primary DI: 07290019388296
• Version / Model: APOS 4 BLACK VELCRO HIGH CUT KNIT 36
• Catalog Number: 222200136
• Company Name: APOS MEDICAL ASSETS LTD
• Labeler DUNS: 532135039
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-24
• Public Version: 1
• Public Version Date: 2022-07-04
• Public Version Status: New
• Public Device Record Key: 1bec1839-4039-4c0b-bab4-487da6773ded

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: Yes
• 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
QDT	Shoe With Adjustable Sole Units	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31043	Orthotic shoe, custom-made	A custom-made footwear designed as a shoe intended to support, align, prevent, and compensate for or correct deformities of the feet to help improve function and/or for post-operative therapy. The device is a standard shoe modified to meet an individual's special orthopaedic requirements. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17290019388293	GS1	Master Box	6	In Commercial Distribution
Primary	07290019388296	GS1

Premarket Submissions

Submission Number	Supplement Number
K182090	000