DEVICE: Tyvek™ Self-Seal Pouch (10732224009015)

Device Identifier (DI) Information

Tyvek™ Self-Seal Pouch
TSP-181
Not in Commercial Distribution

CROSSTEX INTERNATIONAL, INC.
10732224009015
GS1
August 24, 2023
200
057728685 *Terms of Use
Tyvek™ Self-Seal Pouch, 3.5"× 9"/ 9×23cm
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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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FRG Wrap, sterilization
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K123162 000
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
No Device Sizes
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Device Record Status

642eaa04-4f32-47fa-a0aa-1a05405b4ccb
August 25, 2023
2
May 03, 2022
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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
50732224009013 10 10732224009015 2023-08-24 Not 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: 00732224009018 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(585)359-0167
regulatoryaffairs@hu-friedy.com
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