DEVICE: Medline-Microtek (00748426141777)

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Device Record History
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Device Identifier (DI) Information
Medline-Microtek
Equipment Drapes
In Commercial Distribution
3598
Microtek Medical LLC
00748426141777
GS1

1
106908437 *Terms of Use
Microshield™ Microscope Drape for Wild M680, 117 cm x 305 cm (46 in x 120 in)
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
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?
12535 Medical equipment/instrument drape, single-use
A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PUI Drape, Surgical, Exempt
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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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
ec3ec07a-4a25-44e0-aec3-a7ef22bbb590
June 05, 2025
1
May 28, 2025
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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
10748426141774 5 00748426141777 In Commercial Distribution Pack
20748426141771 2 10748426141774 In Commercial Distribution Case
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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

[?]
No Customer Contact currently defined
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