FDA.report

ManaMed

Primary DI
00810113680484
Brand
ManaMed
Company
MANAMED INC
Model
ManaEZ Crutch, Silver
Catalog number
EZCRUTCH01SLVR
Device description
ManaMed's crutches are comfortable and lightweight, comes in pairs. Universal Sizing Height Adjustable
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

Product Codes

CodeName
IPRCrutch

Product Code Classifications

CodeDeviceSpecialtyClass
IPRCrutchPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810113680484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113680484008101136804848101136804840810113680484

GMDN Terms

TermDefinition
Elbow crutchA staff-like mobility aid designed to assist a person with a disability to support their weight while walking. The device has one leg, a padded hand support at the level of the user's wrist, and a non-horizontal plastic or metal cuff that wraps around the forearm. The handgrip is typically made of non-slip material (e.g., rubber, glycerin gel, sheepskin). It may be adjustable in length and is typically made of metal [e.g., aluminium (Al), titanium (Ti)]. This device is commonly used by long-term crutch users because of its lightweight and energy preservation qualities.

Sterilization Methods

Method

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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00810113682853ManaMedManaMed Air Customizable Short MediumMACAIR01-S-M2023-08-28
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00810113682877ManaMedManaMed Air Customizable Short Extra LargeMACAIR01-S-XL2023-08-28
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