APOS 4 221100147

GUDID 17290019388255

APOS MEDICAL ASSETS LTD

Orthotic shoe, custom-made

• Primary Device ID: 17290019388255
• NIH Device Record Key: edd14f2e-4b5f-4dd6-a626-f33ac011a684
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APOS 4
• Version Model Number: APOS 4 GRAY LACE SIZE 47
• Catalog Number: 221100147
• Company DUNS: 532135039
• Company Name: APOS MEDICAL ASSETS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019388258 [Primary]
GS1	17290019388255 [Package]; Contains: 07290019388258; Package: Master Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182090

FDA Product Code

• QDT: Shoe With Adjustable Sole Units

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-30
• Device Publish Date: 2022-06-22

On-Brand Devices [APOS 4]

• 17290019388224: APOS 4 GRAY LACE SIZE 44
• 17290019388217: APOS 4 GRAY LACE SIZE 43
• 17290019388200: APOS 4 GRAY LACE SIZE 42
• 17290019388194: APOS 4 GRAY LACE SIZE 41
• 17290019388187: APOS 4 GRAY LACE SIZE 40
• 07290019388173: APOS 4 GRAY LACE SIZE 39
• 17290019388163: APOS 4 GRAY LACE SIZE 38
• 17290019388156: APOS 4 GRAY LACE SIZE 37
• 07290019388142: APOS 4 GRAY LACE SIZE 36
• 07290019388135: APOS 4 GRAY LACE SIZE 35
• 17290019388286: APOS 4 BLACK VELCRO HIGH CUT KNIT 35
• 17290019388279: APOS 4 GRAY LACE SIZE 49
• 17290019388262: APOS 4 GRAY LACE SIZE 48
• 17290019388255: APOS 4 GRAY LACE SIZE 47
• 17290019388248: APOS 4 GRAY LACE SIZE 46
• 17290019388231: APOS 4 GRAY LACE SIZE 45
• 17290019388422: APOS 4 BLACK VELCRO HIGH CUT KNOT 49
• 17290019388415: APOS 4 BLACK VELCRO HIGH CUT KNOT 48
• 17290019388408: APOS 4 BLACK VELCRO HIGH CUT KNOT 47
• 17290019388392: APOS 4 BLACK VELCRO HIGH CUT KNOT 46
• 17290019388385: APOS 4 BLACK VELCRO HIGH CUT KNOT 44
• 17290019388378: APOS 4 BLACK VELCRO HIGH CUT KNOT 44
• 17290019388361: APOS 4 BLACK VELCRO HIGH CUT KNOT 43
• 17290019388354: APOS 4 BLACK VELCRO HIGH CUT KNOT 42
• 17290019388347: APOS 4 BLACK VELCRO HIGH CUT KNOT 41
• 17290019388330: APOS 4 BLACK VELCRO HIGH CUT KNOT 40
• 17290019388323: APOS BLACK VELCRO HIGH CUT KNIT 39
• 17290019388316: APOS BLACK VELCRO HIGH CUT KNIT 38
• 17290019388309: APOS BLACK VELCROHIGH CUT KNIT 37
• 17290019388293: APOS 4 BLACK VELCRO HIGH CUT KNIT 36