DEVICE: Health-Tec Sterilization Pouches (D773600100041)

Device Identifier (DI) Information

Health-Tec Sterilization Pouches
600-10004
In Commercial Distribution
600-10004
Dental Health Products Inc
D773600100041
HIBCC

200
623191194 *Terms of Use
Health-Tec Sterilization Pouches, 2.75" x 10"
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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
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
JOJ Indicator, Physical/Chemical Sterilization Process
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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

[?]
Size Type Text
Device Size Text, specify: 2.75" x 10"
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Device Record Status

8c01cbf5-23a2-40e8-8bb6-71375d2acdf2
March 29, 2018
2
January 18, 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
D773600100042 20 D773600100041 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: D773600100040 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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