DEVICE: MICROTEK (00748426047284)

Device Identifier (DI) Information

MICROTEK
1
In Commercial Distribution

Microtek Medical LLC
00748426047284
GS1

1
106908437 *Terms of Use
GENERAL PURPOSE PROBE COVER, 3" X 24", 20-PACK
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
44713 Body-surface ultrasound imaging transducer cover
A device/material intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gels) and/or to maintain the required hygienic level of an ultrasound system imaging transducer (probe) used on the body surface during an ultrasound examination. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KKX Drape, surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K882724 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store under normal warehouse conditions.
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Clinically Relevant Size

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

ce48cef6-038a-4b2c-b646-2d2263b840ac
February 05, 2025
7
December 23, 2016
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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
30748426047285 20 00748426047284 In Commercial Distribution
50748426047289 1 30748426047285 In Commercial Distribution
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)824-3027
customerservicemicrotekmed.com@ecolab.com
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