FDA.reportPublic FDA data

Bulk Gel Strip

Primary DI
00614464036132
Brand
Bulk Gel Strip
Company
Silipos Holding LLC
Model
3613
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
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614464036132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614464036132006144640361326144640361320614464036132

GMDN Terms#

Term, Definition table
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 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
00612479282179McKessonMCKESSON MEDICAL-SURGICAL INC.NAD2026-03-17
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30885632495469HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495851HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495868HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495875HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632495882HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632496742HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
20885632496766HalyardOWENS & MINOR DISTRIBUTION, INC.NAD2026-03-13
06974843740574MemGardDalian Orientech Co.,LtdNAD2026-03-10
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06974843740864MemGardDalian Orientech Co.,LtdNAD2026-03-10
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06974843740888MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740895MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740901MemGardDalian Orientech Co.,LtdNAD2026-03-10