DEVICE: Health-Tec EarLoop Masks, Sensitive (D773450100011)

Device Identifier (DI) Information

Health-Tec EarLoop Masks, Sensitive
450-10001
In Commercial Distribution
450-10001
Dental Health Products Inc
D773450100011
HIBCC

50
623191194 *Terms of Use
Health-Tec EarLoop Masks, Sensitive, White
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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 respirator A non-sterile filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the worker and patients from the transfer of microorganisms, blood, body fluids, and airborne particulate materials during medical, surgical, dental, and isolation procedures. It is typically made of multiple layers of non-woven polymers, and incorporates a forming nosepiece (metal wire); it is typically secured using elastic head straps. 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
No CLOSE

Sterilization

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

[?]
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

3cf5ae78-3587-4836-bd09-d58fe769c92f
March 29, 2018
2
January 24, 2017
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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
D773450100013 10 D773450100011 In Commercial Distribution
D773450100015 4 D773450100013 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: D773450100010 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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