DEVICE: Health-Tec Sterilization Pouch (D773600ULT27592)

Device Identifier (DI) Information

Health-Tec Sterilization Pouch
600-ULT2759
In Commercial Distribution
600-ULT2759
Dental Health Products Inc
D773600ULT27592
HIBCC

200
623191194 *Terms of Use
Health-Tec Sterilization Pouch 2.75" x 9"
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
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
Sterilization packaging, single-use A device intended to be used to enclose 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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FDA Product Code

[?]
Product Code Product Code Name
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
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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
Storage Environment Humidity: between 0 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 15 and 35 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 2.75" x 9"
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Device Record Status

e7e98cd5-437b-4fc2-b413-a2d914b6dfca
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
D773600ULT27593 6 D773600ULT27592 In Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: D773600ULT27591 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
8006262163
mhull@dhpi.net
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