DEVICE: Health-Tec Light Handle Sleeves (D773660HT45751)

Device Identifier (DI) Information

Health-Tec Light Handle Sleeves
660-HT4575
In Commercial Distribution
660-HT4575
Dental Health Products Inc
D773660HT45751
HIBCC

500
623191194 *Terms of Use
Health-Tec Light Handle Sleeves, 4" x 5.75"
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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
Operating/examination/treatment light handle cover, single-use A device intended to be used to provide a physical sterile barrier between the operating/examination/treatment light or lighting system and the operating environment during surgical procedures. It will be attached to the light handle, which is typically positioned in the centre of the light head, and may be secured with a built-in locking/affixing mechanism. Surgical staff can change the position of the light(s) without violating their sterility. It is typically made of clear, flexible plastic and is a sterile, single-use device.
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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

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Size Type Text
No Device Sizes
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Device Record Status

e46519ce-920f-46ad-8542-9daf263c65de
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
D773660HT45753 36 D773660HT45751 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: D773660HT45750 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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