FDA.report

ManaMed

Primary DI
00810113680491
Brand
ManaMed
Company
MANAMED INC
Model
ManaEZ Humerus Universal
Catalog number
EZH3980
Device description
This brace is intended for use after an upper arm fracture. It stabilizes the area while allowing motion in the hand and forearm. Lightweight and breathable design Adjustable straps fit any size Can be worn on both right and left arms
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
IQIOrthosis, Limb Brace

Product Code Classifications

CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810113680491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113680491008101136804918101136804910810113680491

GMDN Terms

TermDefinition
External orthopaedic fixation system, single-useAn assembly of devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use 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
false
Sterilization required before use
false

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