DEVICE: Medzah Steel Walkers with 5" Wheels (00860009922730)

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Device Record History
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Device Identifier (DI) Information
Medzah Steel Walkers with 5" Wheels
MDZH904SE
In Commercial Distribution

Medzah Industries
00860009922730
GS1

1
114193536 *Terms of Use
Individual Steel Walkers with 5 inch Wheels - Assembled
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
37951 Handgrip disability-assistive walker, non-powered, foldable
A non-powered, all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and three or four legs designed to provide a stable support for a patient with a walking disability, a geriatric, obese, or infirm patient when standing or ambulating; it may also be used during rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials and in the form of a mobile support structure which the patient holds and pushes in front of them as they walk. It is foldable for storage and transportation and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ITJ Walker, Mechanical
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
2d3c8166-afaf-4ba8-9993-834e97f3cc33
March 17, 2025
1
March 07, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10860009922737 1 00860009922730 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

[?]
860-288-8696
info@medzah.com
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