FDA.reportPublic FDA data

Pad Steris C-Max,4085 & 5085 2 Thick (Set Of 3)

Primary DI
B337BBCMAX1
Brand
Pad Steris C-Max,4085 & 5085 2 Thick (Set Of 3)
Company
FUTURE HEALTH CONCEPTS, INC.
Model
BBCMAX
Catalog number
BBCMAX
Device description
Steris C-Max, 4085 & 5085 Operating Room Table Pad 2 Thick (Set Of 3). 2860 High-Density Polyurethane Foam Non-Latex With Conductive Vinyl Sheeting Top And Bottom Cover With Velcro Kit. This Pad Is Recommended For Shorter Procedures.
Published
2020-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LWGSurgical Table Cushion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B337BBCMAX1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stretcher mattressA large, flat, cushion or pad with a strong cover filled with a resilient material (e.g., foam rubber) designed to be used on a stretcher to provide patient comfort whilst they lie upon it. It is much thinner than a bed mattress and is placed on top of, and typically secured to, the stretcher support platform covering this area. This is a general-purpose device that has no special therapeutic purpose.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
037304144
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B337BB24X75X41FHC Stretcher Pad 24 X 75 X 4 W/Cut CornersBB24X75X4BB24X75X42020-09-22
B337BB24X76X31Stretcher Pad Universal 24 X 76 X 3 Regular CoverBB24X76X3BB24X76X32020-09-22
B337BB26X76X41FHC Stretcher Pad 26 X 76 X 4BB26X76X4BB26X76X42020-09-22
B337BB184541FHC Stretcher Pad W/Cut Corners For FHC7100-29, FHC7101 StretcherBB18454BB184542020-09-16
B337BB20801Pad Amsco 1080/2080 2 Thick (Set Of 3)BB2080BB20802020-09-16
B337BB2080D1Pad Amsco Deluxe 2080 2 Thick (Set Of 3)BB2080DBB2080D2020-09-16
B337BB24X75X4WD1FHC Stretcher Pad With Welded Seams 24 X 75 X 4 W/Cut CornersBB24X75X4WDBB24X75X4WD2020-09-16
B337BB24X76X41Stretcher Pad 24 X 76 X 4 Regular CoverBB24X76X4BB24X76X42020-09-16
B337BB25X75X41Stretcher Pad Standard 25 X 75 X 4 Dura-Comfort CoverBB25X75X4BB25X75X42020-09-16
B337BB26X74X31Stretcher Pad 26 X 74 X 3BB26X74X3BB26X74X32020-09-16
B337BB26X75X41Stretcher Pad 26 X 75 X 4BB26X75X4BB26X75X42020-09-16
B337BB26X76X31FHC Stretcher Pad 26 X 76 X 3BB26X76X3BB26X76X32020-09-16
B337BB26X79X41FHC Stretcher Pad 26 X 79 X 4BB26X79X4BB26X79X42020-09-16
B337BB30801"Pad Amsco (3080/3085) 2"" Thick (Set Of 3)"BB3080BB30802020-09-16
B337BB30X76X31Stretcher Pad 30 X 76 X 3 with Dura-Comfort MaterialBB30X76X3BB30X76X32020-09-16
B337BB735X26X31C-Arm Table Deluxe Pad 73.5 x 26 x 3BB73.5X26X3BB73.5X26X32020-09-16
B337BB7625X2875X41Pad Stretcher 28.75 x 73.25 x 4BB76.25X28.75X4BB76.25X28.75X42020-09-16
B337BBCUSTOMPAD11"FHC Custom Table Pad w/Drain Flap 1"" Purple Fusion, No Velcro"BBCUSTOMPAD-1BBCUSTOMPAD-12020-09-16
B337BBCUSTOMPAD21"FHC Custom 4"" Stretcher Pad w/Black Comfort Cover"BBCUSTOMPAD-2BBCUSTOMPAD-22020-09-16
B337BBFACC0041A1"Pad FHC 1000 Deluxe Patient Transfer Extension 18""W X 25""L X 1""T"BB-FACC0041ABB-FACC0041A2020-09-16

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