FDA.report

ManaMed

Primary DI
00810113680576
Brand
ManaMed
Company
MANAMED INC
Model
ManaEZ Hinged Knee Brace XXX-Large
Catalog number
EZHK1820XXXL
Device description
The ManaEZ Hinged Knee is a convenient wrap on hinged sleeve. The open popliteal feature allows for a comfortable fit. Wrap feature for easy on and off application High quality neoprene Open popliteal
Published
2022-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ITQJoint, Knee, External Brace

Product Code Classifications

CodeDeviceSpecialtyClass
ITQJoint, Knee, External BracePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810113680576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113680576008101136805768101136805760810113680576

GMDN Terms

TermDefinition
Knee orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
888-508-0712support@manamed.com

Regulatory Flags

DUNS number
084042331
Device count
1
DM exempt
false
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

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00810113682662ManaMed IncManaCold Platinum Back PadMCOLDPAD-BACK2023-08-28
00810113682679ManaMed IncManaCold Platinum Hip PadMCOLDPAD-HIP2023-08-28
00810113682785ManaMedManaMed Air Customizable Tall Extra SmallMACAIR01-XS2023-08-28
00810113682792ManaMedManaMed Air Customizable Tall SmallMACAIR01-S2023-08-28
00810113682808ManaMedManaMed Air Customizable Tall MediumMACAIR01-M2023-08-28
00810113682815ManaMedManaMed Air Customizable Tall Large MACAIR01-L2023-08-28
00810113682822ManaMedManaMed Air Customizable Tall Extra LargeMACAIR01-XL2023-08-28
00810113682839ManaMedManaMed Air Customizable Short Extra SmallMACAIR01-S-XS2023-08-28
00810113682846ManaMedManaMed Air Customizable Short SmallMACAIR01-S-S2023-08-28
00810113682853ManaMedManaMed Air Customizable Short MediumMACAIR01-S-M2023-08-28
00810113682860ManaMedManaMed Air Customizable Short LargeMACAIR01-S-L2023-08-28
00810113682877ManaMedManaMed Air Customizable Short Extra LargeMACAIR01-S-XL2023-08-28
00810113682631ManaMed IncKangaroo Sling PillowKSS001-P2023-03-15

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