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"
CLOSE

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
Medical equipment handle cover, single-use, sterile A sterile device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device.
CLOSE

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K160232 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

e46519ce-920f-46ad-8542-9daf263c65de
November 22, 2018
4
January 24, 2017
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: D773660HT45750 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
No
No
Yes
No CLOSE

Customer Contact

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