FDA.reportPublic FDA data

LA Liner, Pin, Tapered, 6mm, Medium

Primary DI
00614464181047
Brand
LA Liner, Pin, Tapered, 6mm, Medium
Company
Silipos Holding LLC
Model
18104
Published
2022-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
IQODevice, Prosthesis Alignment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQODevice, Prosthesis AlignmentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614464181047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614464181047006144641810476144641810470614464181047

GMDN Terms#

Term, Definition table
TermDefinition
External limb prosthesis socket linerA flexible device designed to be fitted inside the socket of an external upper or lower limb prosthesis to form an interface between the socket and the residual limb; it is intended to enable the residual limb to optimally fit the socket by coupling the two together mechanically and/or by pressure differential. It may be made of various textile or synthetic polymer materials (e.g., silicone, thermoplastic elastomer, polyurethane).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056112948
Device count
1
DM exempt
false
Premarket exempt
true
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
00614464350054Malleolar Gel Sleeve, Bulk350052022-08-29
00614464011184Corn Pad, Wide, 6pcs/bag11182022-08-24
00614464011351Extra Comfort Ball of Foot Cushions, 1 Pair/Pkg11352022-08-24
00614464016257Cushion SiloLiner, 6" x 14"16252022-08-24
00614464040016Soft Zone Heel Spur w/Removable Plug, Small, 1pair/box40012022-08-24
00614464040023Soft Zone Heel Spur w/Removable Plug, Medium, 1pair/box40022022-08-24
00614464040030Soft Zone Heel Spur w/Removable Plug, Large, 1pair/box40032022-08-24
00614464040054Softzone Low Profile Heel Cush, Medium, 1pair/box40052022-08-24
00614464040108Softzone Insole, 3/4 Length, Small, 1pair/box40102022-08-24
00614464040115Softzone Insole, 3/4 Length, Medium, 1pair/box40112022-08-24
00614464040122Softzone Insole, 3/4 Length, Large, 1pair/box40122022-08-24
00614464040139Softzone Full Length Insole, Small, 1pair/box40132022-08-24
00614464040146Softzone Full Length Insole, Medium, 1pair/box40142022-08-24
00614464040153Softzone Full Length Insole, Large, 1pair/box40152022-08-24
00614464040160Softzone Full Length Insole, XLarge, 1pair/box40162022-08-24
00614464040207Softzone All Gel Met Pad with Toe Spreader, Small/Medium, 1pair/box40202022-08-24
00614464040214Softzone All Gel Met Pad with Toe Spreader, Large/XLarge, 1pair/box40212022-08-24
00614464040306Softzone Low Profile Fabric Covered Insole, Small, Pair40302022-08-24
00614464042478Bulk Forefoot Pads (Paired Up) No Logo42472022-08-24
00614464042898Softzone Gel Toe Separator, Large, Wide, Bulk, 100pcs/bag42892022-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841747186912Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2025-05-28
00841747186929Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2025-05-28
00195411036455Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411036622Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411036790Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411036813Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411108602Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192298Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192304Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192311Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192328Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192342Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192359Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192366Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192373Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192380Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192397Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192403Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192410Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192427Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192434Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411214440Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411214457Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269150Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269167Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269174Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269181Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269198Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269204Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269211Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26