DEVICE: BUPRENORPHINE PLUS LEVEL 2 (B80003716500060)

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Device Record History
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Device Identifier (DI) Information
BUPRENORPHINE PLUS LEVEL 2
BUP+ 2 U PM
In Commercial Distribution

UTAK LABORATORIES, INC.
B80003716500060
HIBCC

1
092519016 *Terms of Use
BUPRENORPHINE PLUS LEVEL 2
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
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?
55723 Opiate/opiate metabolite IVD, control
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of opiate and/or opiate metabolites in a clinical specimen.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LAS Drug Specific Control Materials
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes 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
533cced2-cf28-4802-b71d-277ff174db00
June 29, 2022
1
June 21, 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
B80003716500061 4 B80003716500060 In Commercial Distribution Box
B80003716500062 5 B80003716500060 In Commercial Distribution Box
B80003716500063 10 B80003716500060 In Commercial Distribution Box
B80003716500066 25 B80003716500060 In Commercial Distribution Box
B80003716500067 50 B80003716500060 In Commercial Distribution Box
B80003716500068 100 B80003716500060 In Commercial Distribution Box
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(888) 882-5522
welovecontrol@utak.com
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