DEVICE: T-tek (10859394006054)

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Device Record History
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Device Identifier (DI) Information
T-tek
50-201
In Commercial Distribution
50-201
R 2 DIAGNOSTICS, INC.
10859394006054
GS1

10
956610125 *Terms of Use
Thrombin Time 10 x 1 ml
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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?
55987 Thrombin time (TT) IVD, kit, clotting
A collection of reagents and other associated materials intended to be used for the quantitative measurement of the thrombin time (TT) of a clinical specimen using a clotting method.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GJA Test, Thrombin Time
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K050817 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
b4606a44-5e26-4524-aa88-5c9b8b6a173a
July 06, 2018
3
November 15, 2016
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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
No Package DIs found
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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: 00859394006057 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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