DEVICE: Health-Tec Sterilization Pouch (D773600ULT355252)
Device Identifier (DI) Information
Health-Tec Sterilization Pouch
600-ULT35525
In Commercial Distribution
600-ULT35525
Dental Health Products Inc
600-ULT35525
In Commercial Distribution
600-ULT35525
Dental Health Products Inc
Health-Tec Sterilization Pouch 3.5" x 5.25"
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
13735 | Sterilization packaging, single-use |
A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity |
Storage Environment Temperature: between 15 and 35 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 3.5" x 5.25" |
Device Record Status
c680ace4-ea8f-4dba-aadb-bbc0bfe916ae
November 08, 2019
3
January 24, 2017
November 08, 2019
3
January 24, 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 |
---|---|---|---|---|---|
D773600ULT355253 | 5 | D773600ULT355252 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D773600ULT355251
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
8006262163
mhull@dhpi.net
mhull@dhpi.net