FDA.report

Bulk 5"X6" Gel Sheet

Primary DI
00614464036101
Brand
Bulk 5"X6" Gel Sheet
Company
Silipos Holding LLC
Model
3610
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
NADDressing, Wound, Occlusive

Product Code Classifications

CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00614464036101PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00614464036101006144640361016144640361010614464036101

GMDN Terms

TermDefinition
Custom-made cushionA soft pillow or pad that is specially designed for an individual to provide support, comfort, or assist the user to fulfill a functional requirement.

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

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 DIBrandCompanyProduct codePublished
00612479282179McKessonMCKESSON MEDICAL-SURGICAL INC.NAD2026-03-17
06974795053920MEDLOTHenan Maidingkang Medical Technology Co., Ltd.NAD2026-03-13
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
06974843740581MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740598MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740604MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740741MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740758MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740765MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740772MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740789MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740796MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740802MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740819MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740826MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740833MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740840MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740857MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740864MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740871MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740888MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740895MemGardDalian Orientech Co.,LtdNAD2026-03-10
06974843740901MemGardDalian Orientech Co.,LtdNAD2026-03-10