FDA.reportPublic FDA data

UKnee Suspended Knee Positioner

Primary DI
00696588007786
Brand
UKnee Suspended Knee Positioner
Company
Innovative Medical Products, Inc
Model
824-P
Catalog number
824-P
Device description
Sterile Pad Set for UKnee Suspended Knee Positioner (6 sets/case)
Published
2024-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
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
00696588007793PrimaryGS10
00696588007786Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00696588007793006965880077936965880077930696588007793
00696588007786006965880077866965880077860696588007786

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic knee/leg holder linerA sterile pad/cover designed to be placed between a patient's leg and an orthopaedic knee/leg holder, cushioning the leg to reduce the risk of damage of the skin/muscles/nerves during an orthopaedic procedure (e.g., arthroscopy, arthroplasty). It is typically made of disposable plastic material (e.g., a foam) with an appropriate shape and size to fit the holder. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
147363154
Device count
6
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
Primary DIBrandCompanyProduct codePublished
00089904011503Action®ACTION PRODUCTS, INC.FMP2026-09-30
07333350181475Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350455873Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350647292Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350743918Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350775360Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-22
07333350462161Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350529079Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
07333350768249Mölnlycke®Z-Flo™ Fluidized PositionerMölnlycke Health Care ABFMP2026-09-21
00860015694713Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694720Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694737Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694744Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694751Prism WedgePrism Pacific Industries LLCFMP2026-08-27
00860015694768Prism WedgePrism Pacific Industries LLCFMP2026-08-27
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