DEVICE: Health-Tec Barrier Film (D773660HT46C1)

Device Identifier (DI) Information

Health-Tec Barrier Film
660-HT46C
In Commercial Distribution
660-HT46C
Dental Health Products Inc
D773660HT46C1
HIBCC

1200
623191194 *Terms of Use
Health-Tec Barrier Film, 4" x 6", Clear
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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
Instrument/equipment drape, single-use, non-sterile A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device. See also: Instrument tray liner
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FDA Product Code

[?]
Product Code Product Code Name
PEM Dental Barriers And Sleeves
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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

[?]
Size Type Text
Device Size Text, specify: 4" x 6"
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Device Record Status

8d8e9bcd-e5f7-4548-ad5b-0f831cdf7d28
March 29, 2018
2
January 18, 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
D773660HT46C3 12 D773660HT46C1 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

[?]
Unit of Use DI Number: D773660HT46C0 CLOSE

Direct Marking (DM)

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

[?]
No
No
No
Yes
No CLOSE

Customer Contact

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