FDA.reportPublic FDA data

Repose Extra Small Footprotector Plus (Bulk Pack 10) with Pump

Primary DI
05056279302432
Brand
Repose Extra Small Footprotector Plus (Bulk Pack 10) with Pump
Company
Frontier Therapeutics Inc
Model
6550100
Device description
Repose Extra Small Footprotector Plus (Bulk Pack 10) with Pump
Published
2021-03-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
05056279302432PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056279302432050562793024325056279302432

GMDN Terms#

Term, Definition table
TermDefinition
Heel protectorA device that is designed to be worn over the foot to provide a cushion to protect the heel from friction against surfaces and knocks against objects; the toes will protrude and not be protected. It is typically made from soft padded materials and is held in place with bands or straps around the foot or the foot can be slid into it like a sock. It is typically used by persons that have tendencies for skin sores on their heels, are bedridden, or prone to lack of control with their legs causing injury to the heels. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)303-9544contactus@frontier-therapeutics.com

Regulatory Flags#

DUNS number
111598708
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056279301428Repose Mattress and Pump (Bulk Pack 10)6111002021-03-31
05056279301602Repose Cushion (Bulk Pack 10)62001012021-03-31
05056279302029Repose Footprotector (Pair) (Bulk Pack 10)65002002021-03-31
05056279302036Repose Long Footprotectors (Pair) (Bulk Pack 10)65002012021-03-31
05056279302258Repose Footprotector PLUS (Pair) (Bulk Pack 10)65111102021-03-31
05056279302296Repose Small Footprotector (Bulk Pack 10) with Pump65201002021-03-31
05056279302340Repose Extra Small Footprotector (Bulk Pack 10) with Pump65301002021-03-31
05056279302395Repose Small Footprotector Plus (Bulk Pack 10) with Pump65401002021-03-31
05056279302425Repose Small Footprotectors Plus (Single) and Pump65411032021-03-31
05056279303279Repose Sole Protector x 1 with Small Pump69300012021-03-31
05056279303521Repose Trolley Mattress and Pump (10 Singles)76011002021-03-31
05056279303613Repose Mattress Overlay and Pump (10 Singles)70111002021-03-31
05056279303620Repose 1 Long Footprotector and Pump (10 Singles)70210002021-03-31
05056279303637Repose Long Footprotectors (pair) and Pump - 10 Singles70211002021-03-31
05056279303682Repose Mattress Cushion and Pump (10 Singles)71211012021-03-31
05056279303743Repose Cushion and Pump (10 Singles)72011002021-03-31
05056279303774Repose Babytherm and Pump (10 Singles)74011002021-03-31
05056279303781Repose Single Footprotector and Pump 10 Singles75010202021-03-31
05056279303804Repose Footprotectors (Pair) and Pump (10 Singles)75011002021-03-31
05056279303835Repose Footprotector PLUS (Pair) and Pump - 10 Singles75111002021-03-31

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