DEVICE: Practicon Face Shields (00723896017654)

Device Identifier (DI) Information

Practicon Face Shields
Practicon Face Shields
In Commercial Distribution
7039733
PRACTICON, INC.
00723896017654
GS1

10
119193803 *Terms of Use
The Protective Face Shield offers full-face protection with a soft, detachable elastic headband. 1 1/4" thick permanently adhered foam pad supports the antifog shield over most eyewear and loupes. Wash with soap and water and allow to air dry. 10 per box.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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No
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GMDN

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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?
11961 Face splash shield, single-use
A clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.
Active false
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FDA Product Code

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Product Code Product Code Name
LYU Accessory, Surgical Apparel
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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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4a3e4ce6-e8a4-4b9f-93d5-61c6d983744c
July 21, 2020
1
July 13, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00723896005033 100 00723896017654 In Commercial Distribution Case
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Secondary DI

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

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Unit of Use DI Number: 00723896005026 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
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No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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