FDA.reportPublic FDA data

Action®

Primary DI
00089904007667
Brand
Action®
Company
ACTION PRODUCTS, INC.
Model
OR Table Replacement Pad
Catalog number
50330B
Device description
Performance Plus 2in. Skytron
Published
2021-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00089904007667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00089904007667000899040076670899040076670089904007667

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient pressure distribution 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Minimal UV exposure
Special Storage Condition, Specify00Store in clean, dry environment

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
301.797.1414service@actionproducts.com

Regulatory Flags#

DUNS number
067543058
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00089904002297Action®Mattress Overlay6400H2021-02-03
00089904002310Action®Mattress Overlay6405H2021-02-03
00089904002280Action®Mattress Overlay64002021-01-21
00089904002303Action®Mattress Overlay64052021-01-21
00089904011374Action®OR Table Replacement Pad70915A2026-01-08
00089904011381Action®OR Table Replacement Pad779102026-01-08
00089904011398Action®OR Table Replacement Pad55915C2026-01-08
00089904011367Action®OR Table Replacement Pad75910D2025-11-18
00089904000958Action®Arm Pad403122021-01-11
00089904011350Action®OR Table Replacement Pad57140C2025-08-28
00089904011343Action®OR Table Replacement Pad721402025-01-06
00089904011336Action®OR Table Replacement Pad57310C2024-09-10
00089904009531Action®Disposable Cover40616DC2021-01-14
00089904009548Action®Disposable Cover40617DC2021-01-14
00089904009555Action®Disposable Cover40618DC2021-01-14
00089904009562Action®Disposable Cover40619DC2021-01-14
00089904009579Action®Disposable Cover40620DC2021-01-14
00089904009586Action®Disposable Cover40621DC2021-01-14
00089904000231Action®Disposable Cover40102I2021-01-14
00089904000422Action®Disposable Cover401022021-01-11

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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00609271166042DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166059DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166066DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
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00609271166080DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166097DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166103DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166110DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166127DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166134DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166141DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166158DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166165DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166172DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08
00609271166189DARCO® PegContour™ InsoleDarco (Europe) GmbHFMP2023-02-08