DEVICE: EXCEL PLUS COMPLY QUILTED PAD (00634916006995)

Device Identifier (DI) Information

EXCEL PLUS COMPLY QUILTED PAD
61064100
In Commercial Distribution
61064100
STANDARD TEXTILE CO., INC.
00634916006995
GS1

24
006999858 *Terms of Use
EXCEL PLUS COMPLY QUILTED PAD 30X36 10.5 OZ VINYL LAMINATED
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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

944a9408-e5a1-4e7e-8615-be5bdac8a8e3
July 28, 2023
4
January 29, 2018
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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: 10634916079286 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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