FDA.reportPublic FDA data

TrenMAX™

Primary DI
00696588003856
Brand
TrenMAX™
Company
Innovative Medical Products, Inc
Model
415
Catalog number
415
Device description
TrenMAX™ Pad (5 per case)
Published
2019-10-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00696588003856PrimaryGS10
00696588000749Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00696588003856006965880038566965880038560696588003856
00696588000749006965880007496965880007490696588000749

GMDN Terms#

Term, Definition table
TermDefinition
Trendelenburg positioning padA non-sterile cushioned device intended to be placed between an operating table mattress and a patient’s back to secure the patient to the table while placing them in the Trendelenburg position during surgery. It typically consists of a flat pad with a pressure-sensitive adhesive, intended to contact patient skin, and additional devices for securing the patient and pad to the operating table (e.g., arm straps, adaptors/clamps); it may also be intended to aid in distributing patient body weight over a larger surface area and in preventing pressure sores and tissue necrosis on prominent parts of the body during the procedure. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
147363154
Device count
5
DM exempt
true
Premarket exempt
true
Lot or batch
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

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07333350743918Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
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07333350529079Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
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