FDA.report

"Day & Night Gel Bunion Splint, 1pc/bag (w/ gel piece) "

Primary DI
00614464928345
Brand
"Day & Night Gel Bunion Splint, 1pc/bag (w/ gel piece) "
Company
Silipos Holding LLC
Model
92834
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
00614464928345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00614464928345006144649283456144649283450614464928345

GMDN Terms

TermDefinition
Foot orthosisA device designed to encompass the whole or part of the foot, or designed as a plantar insert, and intended to provide rigid or semi-rigid correction of the foot for persons with orthopaedic deformities/injuries of the feet; it may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds. It is typically made of metal, synthetic, and/or textile materials and may include customizable plantar inserts. This is a single-patient use device that can be reapplied to the patient during the treatment period (reusable) before being discarded.

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

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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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