FDA.reportPublic FDA data

TUFFease®

Primary DI
00696588006413
Brand
TUFFease®
Company
Innovative Medical Products, Inc
Model
TE-309
Catalog number
TE-309
Device description
"TUFFease® Armboard Pad: Wide, Short 15"" x 6"" x 1/4""`"
Published
2020-10-30
Public version status
Update
Distribution status
Not 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
00696588006413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00696588006413006965880064136965880064130696588006413

GMDN Terms#

Term, Definition table
TermDefinition
Operating table pad, reusableA cushion (e.g., gel-filled, foam) intended to be placed between an operating table mattress or a patient positioner (e.g., torso intraoperative positioner, perineal post) and the patient to distribute the patient's body weight over a large surface area, for the prevention of pressure sores and tissue necrosis on prominent parts of the patient's body when immobilized for extended periods during surgery. It is available in various dimensions and shapes to accommodate various body parts such as the buttocks, shoulders, heels, or the entire body (usually excluding the head). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
147363154
Device count
1
DM exempt
true
Premarket exempt
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00696588008394De Mayo D2® Knee Positioner®803-114-CN-6803-114-CN-62026-06-23
00696588008370MorphBoard®105-CPX105-CPX2026-05-19
00696588008325De Mayo Adapt2Fit® Modular Knee Positioner 1020-717-SYS KIT DEMO1020-717-SYS KIT DEMO2026-04-07
00696588008264De Mayo Adapt2Fit® Modular Knee Positioner 1020-717-SYS KIT-PS1020-717-SYS KIT-PS2026-04-02
00696588008271De Mayo Adapt2Fit® Modular Knee Positioner 1020-717-621-SYS KIT-PS1020-717-621-SYS KIT-PS 2026-04-02
00696588008288De Mayo Adapt2Fit® Modular Knee Positioner 1020-923-717-SYS KIT-PS1020-923-717-SYS KIT-PS2026-04-02
00696588008295De Mayo Adapt2Fit® Modular Knee Positioner 1020-923-717-621-SYS KIT-PS1020-923-717-621-SYS KIT-PS2026-04-02
00696588008301De Mayo D2® Knee Positioner®803-114-A713-7-PS803-114-A713-7-PS2026-04-02
00696588008318De Mayo D2® Knee Positioner®803-114-621-A713-7-PS803-114-621-A713-7-PS2026-04-02
00696588008189HipFit-ULP™325-BP325-BP2025-10-15
00696588008196HipFit-ULP™325-LB325-LB2025-10-15
00696588008202HipFit-ULP™325-AN325-AN2025-10-15
00696588008219HipFit-ULP™325-KIT325-KIT2025-10-17
00696588008226HipFit-ULP™325-SYS KIT325-SYS KIT2025-10-17
00696588008257De Mayo Universal Distractor®621AS621AS2026-01-20
00696588008240De Mayo Adapt2Fit® Modular Knee Positioner 1020-923-717-SYS KIT LOANER1020-923-717-SYS KIT LOANER2025-12-16
00696588008233De Mayo Adapt2Fit® Modular Knee Positioner 1020-DP-111020-DP-112025-11-21
00696588008165De Mayo Adapt2Fit® Modular Knee Positioner 1020-LRP1020-LRP2025-09-17
00696588008172De Mayo Adapt2Fit® Modular Knee Positioner 1020-UPGRADE KIT1020-UPGRADE KIT2025-09-17
00696588008141De Mayo Adapt2Fit® Modular Knee Positioner 1020-PRK1020-PRK2025-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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00089904011404Action®ACTION PRODUCTS, INC.FMP2026-06-08
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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