DEVICE: Health-Tec Barrier Film (D773660HT46B1)
Device Identifier (DI) Information
Health-Tec Barrier Film
660-HT46B
In Commercial Distribution
660-HT46B
Dental Health Products Inc
660-HT46B
In Commercial Distribution
660-HT46B
Dental Health Products Inc
Health-Tec Barrier Film, 4" x 6" Blue
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
61049 | 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.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PEM | Dental Barriers And Sleeves |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K160232 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 4" x 6" |
Device Record Status
d4258480-1c18-43e8-8173-040103e2c9cb
July 06, 2018
3
January 18, 2017
July 06, 2018
3
January 18, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D773660HT46B3 | 12 | D773660HT46B1 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D773660HT46B0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-626-2163
mhull@dhpi.net
mhull@dhpi.net