DEVICE: maxill Silken Tie-on Style Procedural Masks, Green (00060705530134)

Device Identifier (DI) Information

maxill Silken Tie-on Style Procedural Masks, Green
53013
In Commercial Distribution

MAXILL, INC.
00060705530134
GS1

50
079343581 *Terms of Use
No description.
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Surgical face mask, single-use A device intended to be placed over the nose and mouth of medical personnel to prevent the transmission of airborne organisms during surgery or patient examination. It is made of a flexible porous fabric material that allows the user to breath normally through the mask and typically includes a metal wire along one border to form fit the nose bridge; it is typically held in place with ties that fasten at the back of the user's head. This is a single-use device.
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FDA Product Code

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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
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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

8d55955a-aec5-4da2-9221-f761c8a2764c
March 29, 2018
2
September 16, 2016
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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
No Package DIs found
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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: 90060705530137 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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