DEVICE: Easy Mount™ 9 Hole Flange w/Cover (12" knurled steel) (00689281007016)

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Device Record History
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Device Identifier (DI) Information
Easy Mount™ 9 Hole Flange w/Cover (12" knurled steel)
G125SK12F9
In Commercial Distribution
00710
Healthcraft Products Inc.
00689281007016
GS1

1
252468293 *Terms of Use
A high quality 12" knurled steel grab bar that is fixed to the wall and is intended to provide a person with a disability a supportive hand-hold whilst standing and moving. This grab bar may be installed in any room of the home.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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?
35586 Hand rail
A device that is fixed to the wall and is of differing bar shaped designs that is intended to provide a person with a disability a supportive hand-hold whilst standing and moving.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IKX Aid, Transfer
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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
6b3e0ab3-89e7-44b7-88e9-e4593da1165c
September 02, 2021
1
August 25, 2021
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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
10689281007013 10 00689281007016 In Commercial Distribution 10 - pack
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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)

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Yes
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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