FDA.report

Digital Caps, Black, Bulk

Primary DI
00614464317064
Brand
Digital Caps, Black, Bulk
Company
Silipos Holding LLC
Model
31706
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

Related Records

Product Codes

CodeName
FMPProtector, Skin Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00614464317064PrimaryGS10

GMDN Terms

TermDefinition
Foot friction/impact protectorA device designed to be worn over/on the foot, often while wearing shoes, to provide a cushion to protect the whole foot or parts of the foot (e.g., toes, metatarsal heads, heel) from friction against surfaces or knocks against objects, to relieve pain during walking, and/or to prevent formation of hard areas and callouses. It is typically made of soft-padded or gel materials in a variety of forms (e.g., strip, pad, elastic band, digital tube), and some types may be inflatable or held in place with bands or straps around the foot. It is not specifically designed to protect a bunion. This is a reusable device.

Sterilization Methods

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

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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

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