DEVICE: Health-Tec Earloop Masks (D773450100201)

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Device Identifier (DI) Information

Health-Tec Earloop Masks
450-10020
450-10020
Dental Health Products Inc
D773450100201
HIBCC
50
Health-Tec Earloop Masks, Level 1, Blue
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Device Characteristics

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

GMDN

[?]

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
MSH Respirator,Surgical
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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 Status

In Commercial Distribution
January 17, 2017

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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
D773450100202 10 D773450100201 In Commercial Distribution
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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: D773450100200 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
Yes
No CLOSE

Customer Contact

[?]
800-626-2163
mhull@dhpi.net
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