DEVICE: Euro Tech Underpad (00634916504705)

Device Identifier (DI) Information

Euro Tech Underpad
59750200
In Commercial Distribution
59750200
STANDARD TEXTILE CO., INC.
00634916504705
GS1

24
006999858 *Terms of Use
Euro Tech Plus Quilted Underpad, 1 Ply laminated with PU Barrier
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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?
66117 Absorbent underpad, non-antimicrobial, reusable
A flat piece of absorbent fabric material (e.g., polyester, cotton) intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids (typically urine associated with bladder weakness/incontinence); it does not include an antimicrobial agent(s). It is intended to be used in the healthcare facility and in the home. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FMW Cover, Mattress (Medical Purposes)
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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

445145ee-b01c-4ada-8c83-367b2c81ab0f
July 31, 2023
3
April 03, 2020
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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
No Package DIs found
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Secondary DI

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

[?]
Unit of Use DI Number: 10634916504702 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
1-800-999-0400
GUDID@standardtextile.com
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