DEVICE: Ever-Soft Positioning Wedge (00840117307766)

Device Identifier (DI) Information

Ever-Soft Positioning Wedge
13003
In Commercial Distribution

Dynarex Corporation
00840117307766
GS1

1
008124539 *Terms of Use
Positioning Wedge 8"x8"x35" 45 Degrees
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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?
63407 Assistive sleeping cushion set
A collection of cushions, pads, pillows and bolsters intended to provide support and optimal positioning for a disabled person during sleep. The items are typically made of soft textile or synthetic materials and include pieces designed for specific body parts (e.g., head, shoulders, back, hips, knees, feet) used during different sleeping positions (supine, side, or prone lying). This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IMP Cushion, Wheelchair
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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

[?]
Size Type Text
No Device Sizes
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Device Record Status

d590595b-44a1-4d78-a6f3-1628bb8589b1
October 09, 2024
2
April 22, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00616784300344 2 00840117307766 In Commercial Distribution Shipper
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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

[?]
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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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