FDA.reportPublic FDA data

"Gel-E-Roll, 4"" x 48"", 1roll/box"

Primary DI
00614464103551
Brand
"Gel-E-Roll, 4"" x 48"", 1roll/box"
Company
Silipos Holding LLC
Model
10355
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
00614464103551PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00614464103551006144641035516144641035510614464103551

GMDN Terms#

Term, Definition table
TermDefinition
Scar management dressing, single-use, non-sterileA non-sterile covering/substance made of, or coated with, a synthetic polymer material (e.g., silicone gel, polyurethane) intended to be applied directly to the skin for the management of hypertrophic or keloid scars. The device is typically in the form of a flexible or elastic sheet/film, foam, or gel that occludes the skin to hydrate and reduce/prevent red, dark, or raised scars resulting from surgery, accidents, cuts, burns, or other injuries. The device may be self-adhesive or fixed by tape; devices/accessories associated with application may be included (e.g., massage ball). After application, this device cannot be reused.

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
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