FDA.reportPublic FDA data

"Soft Shear Sheeting, 12""x 16"", Fabric on 1 Side"

Primary DI
00614464157059
Brand
"Soft Shear Sheeting, 12""x 16"", Fabric on 1 Side"
Company
Silipos Holding LLC
Model
15705
Published
2022-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00614464157059PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614464157059006144641570596144641570590614464157059

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
056112948
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614464141157Post Operative Carpal Sleeve, Small, Left141152022-08-05
00614464141256Post Operative Carpal Sleeve, Small Right141252022-08-05
00614464141355Post Operative Carpal Sleeve, Large, Left141352022-08-05
00614464141454Post Operative Carpal Sleeve, Large, Right141452022-08-05
00614464141652Carpal Sleeve with 2 Thumb Holes141652022-08-05
00614464142055Carpal Pads With Pres. Sens.142052022-08-05
00614464341656Carpal Sleeve with 2 Thumb Holes - Bulk341652022-08-05
00614464928956Foam Toe Separator (Sheet of 12), Small, 1sheet/bag928952022-08-05
00614464928963Foam Toe Separator (Sheet of 12), Medium, 1sheet/bag928962022-08-05
00614464928970Foam Toe Separator (Sheet of 12), Large, 1sheet/bag928972022-08-05
00614464928987Foam Toe Separator (Sheet of 12), X-Large, 1sheet/bag928982022-08-05
00614464928994"""Deluxe Suede Hammer Toe Crest, Small, Left, 3pcs/bag """928992022-08-05
00614464929007"""Deluxe Suede Hammer Toe Crest, Small, Right, 3pcs/bag """929002022-08-05
00614464929014"""Deluxe Suede Hammer Toe Crest, Medium, Left, 3pcs/bag """929012022-08-05
00614464929021"""Deluxe Suede Hammer Toe Crest, Medium, Right, 3pcs/bag """929022022-08-05
00614464929038"""Deluxe Suede Hammer Toe Crest, Large, Left, 3pcs/bag """929032022-08-05
00614464929045"""Deluxe Suede Hammer Toe Crest, Large, Right, 3pcs/bag """929042022-08-05
00614464929052"""Felt Hammer Toe Crest, Small, Left, 3pcs/bag """929052022-08-05
00614464929069"""Felt Hammer Toe Crest, Small, Right, 3pcs/bag """929062022-08-05
00614464929076"""Felt Hammer Toe Crest, Medium, Left, 3pcs/bag """929072022-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333350181475Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350455873Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350647292Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350743918Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350775360Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350462161Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350529079Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350768249Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
00860015694713Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694720Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694737Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694744Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694751Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694768Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00089904011459Action®ACTION PRODUCTS, INC.FMP2026-07-23
00089904011435Action®ACTION PRODUCTS, INC.FMP2026-07-21
00089904011442Action®ACTION PRODUCTS, INC.FMP2026-07-21
00609271999336Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999343Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999374Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999381Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999473Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00609271999480Aircore™ InsoleDARCO INTERNATIONAL, INC.FMP2026-07-20
00089904011428Action®ACTION PRODUCTS, INC.FMP2026-07-17
00089904011411Action®ACTION PRODUCTS, INC.FMP2026-07-06
00816299013337HoverMatt PROSWedgeHovertech InternationalFMP2026-07-06
00089904011404Action®ACTION PRODUCTS, INC.FMP2026-06-08
00505627930841Repose Flex Large x10 &Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308434Repose Flex Large x1 & Pump x1Frontier Therapeutics IncFMP2026-06-05
05056279308458Repose Flex Large x10 &Pump x10Frontier Therapeutics IncFMP2026-06-05