FDA.reportPublic FDA data

SteriBump®

Primary DI
00696588006949
Brand
SteriBump®
Company
Innovative Medical Products, Inc
Model
508-S
Catalog number
508-S
Device description
SteriBump® UE Sterile (5/case)
Published
2022-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00696588006949PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00696588006949006965880069496965880069490696588006949

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
147363154
Device count
1
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
05056279308458Repose Flex Large x10 &Pump x10Frontier Therapeutics IncFMP2026-06-05