FDA.reportPublic FDA data

Foam Toe Separator (Sheet of 12), Medium, 1sheet/bag

Primary DI
00614464928963
Brand
Foam Toe Separator (Sheet of 12), Medium, 1sheet/bag
Company
Silipos Holding LLC
Model
92896
Published
2022-08-05
Public version status
Update
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
00614464928963PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614464928963006144649289636144649289630614464928963

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose medical foam padding, reusableA roll, sheet or preformed shape of synthetic latex foam material [e.g., styrene-butadiene rubber (SBR)] intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a reusable device.

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
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
00614464929083"""Felt Hammer Toe Crest, Medium, Right, 3pcs/bag """929082022-08-05

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Primary DI, Brand, Company table
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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
00860010482674AcanthusAcanthus Medical Creations LLCFMP2026-05-27
10603354600666TruVueEHOB INCFMP2025-03-20
10603354300696WAFFLEEHOB INCFMP2024-12-18
07613327632873Sage TAP LCSAGE PRODUCTS, LLCFMP2024-03-26
G096R9292209LineRising Eagle Medical LLCFMP2024-01-30
20845854082536Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082901Paradigm RevolutionConmed CorporationFMP2023-06-13
20845854082918Paradigm RevolutionConmed CorporationFMP2023-06-13
00609271009004DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009011DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009103DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271009110DARCO® Body Armor® Toe GuardDARCO INTERNATIONAL, INC.FMP2023-02-08
00609271166004DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166011DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08