APOS 4

Primary DI
17290019388422
Brand
APOS 4
Company
APOS MEDICAL ASSETS LTD
Model
APOS 4 BLACK VELCRO HIGH CUT KNOT 49
Catalog number
222200149
Published
2022-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
QDTShoe With Adjustable Sole Units

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDTShoe With Adjustable Sole UnitsPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182090000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182090000AposTherapy SystemApos Medical Assets , Ltd.2018-11-16QDT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290019388422PackageGS16In Commercial Distribution
07290019388425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729001938842217290019388422
07290019388425072900193884257290019388425

GMDN Terms#

Term, Definition table
TermDefinition
Orthotic shoe, custom-madeA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532135039
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019388296APOS 4APOS 4 BLACK VELCRO HIGH CUT KNIT 362222001362022-06-24
07290019388302APOS 4APOS BLACK VELCROHIGH CUT KNIT 372222001372022-06-24
07290019388319APOS 4APOS BLACK VELCRO HIGH CUT KNIT 382222001382022-06-24
07290019388326APOS 4APOS BLACK VELCRO HIGH CUT KNIT 392222001392022-06-24
07290019388333APOS 4APOS 4 BLACK VELCRO HIGH CUT KNOT 402222001402022-06-24
07290019388340APOS 4APOS 4 BLACK VELCRO HIGH CUT KNOT 412222001412022-06-24
07290019388357APOS 4APOS 4 BLACK VELCRO HIGH CUT KNOT 422222001422022-06-24
07290019388364APOS 4APOS 4 BLACK VELCRO HIGH CUT KNOT 432222001432022-06-24
07290019388371APOS 4APOS 4 BLACK VELCRO HIGH CUT KNOT 442222001442022-06-24
07290019388388APOS 4APOS 4 BLACK VELCRO HIGH CUT KNOT 442222001452022-06-24
07290019388395APOS 4APOS 4 BLACK VELCRO HIGH CUT KNOT 462222001462022-06-24
07290019388401APOS 4APOS 4 BLACK VELCRO HIGH CUT KNOT 472222001472022-06-24
07290019388418APOS 4APOS 4 BLACK VELCRO HIGH CUT KNOT 482222001482022-06-24
07290019388425APOS 4APOS 4 BLACK VELCRO HIGH CUT KNOT 492222001492022-06-24
17290019388293APOS 4APOS 4 BLACK VELCRO HIGH CUT KNIT 362222001362022-06-24
17290019388309APOS 4APOS BLACK VELCROHIGH CUT KNIT 372222001372022-06-24
17290019388316APOS 4APOS BLACK VELCRO HIGH CUT KNIT 382222001382022-06-24
17290019388323APOS 4APOS BLACK VELCRO HIGH CUT KNIT 392222001392022-06-24
17290019388330APOS 4APOS 4 BLACK VELCRO HIGH CUT KNOT 402222001402022-06-24
17290019388347APOS 4APOS 4 BLACK VELCRO HIGH CUT KNOT 412222001412022-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019388296APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
07290019388302APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
07290019388319APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
07290019388326APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
07290019388333APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
07290019388340APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
07290019388357APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
07290019388364APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
07290019388371APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
07290019388388APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
07290019388395APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
07290019388401APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
07290019388418APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
07290019388425APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
17290019388293APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
17290019388309APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
17290019388316APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
17290019388323APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
17290019388330APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
17290019388347APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
17290019388354APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
17290019388361APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
17290019388378APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
17290019388385APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
17290019388392APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
17290019388408APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
17290019388415APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-24
07290019388159APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-22
07290019388166APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-22
07290019388180APOS 4APOS MEDICAL ASSETS LTDQDT2022-06-22