DEVICE: Medichoice (10885632100741)

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Device Record History
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Device Identifier (DI) Information
Medichoice
PG4-5073
In Commercial Distribution

OWENS & MINOR DISTRIBUTION, INC.
10885632100741
GS1

25
007941230 *Terms of Use
Surgical Face Mask Tie Primasoft 160 Anti Fog Foam With Alumin Not Made With Natural Rubber Latex Blue Latex Free MediChoice
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
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?
58376 Eye splash shield, single-use
A device intended to be worn over the eyes to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It may have an open design like spectacles, or an enclosed design like goggles or a mask. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FXX Mask, surgical
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify:
Special Storage Condition, Specify: Store in cool, dry, and well ventilated space out of direct sunlight
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
18565f06-5052-49cd-98fe-dada92db2cdf
October 16, 2020
5
August 20, 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
50885632100749 4 10885632100741 In Commercial Distribution
20885632100748 90 50885632100749 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: 60885632100746 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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