DEVICE: Pinnacle Cure Sleeve (00615375004746)

Device Identifier (DI) Information

Pinnacle Cure Sleeve
DEMIULTRA-100C
In Commercial Distribution

METREX RESEARCH, LLC
00615375004746
GS1

100
145963778 *Terms of Use
CustomFitted for the Kerr Demi Ultra LED Curing Light with UltraSoft Material
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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?
61049 Instrument/equipment drape, single-use, non-sterile
A non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
MMP Cover, barrier, protective
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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
No Device Sizes
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Device Record Status

503dea7c-02e1-4ed4-8a19-1664684a36a1
March 29, 2018
2
February 15, 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
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
HIBCC D683DEMIULTRA100
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Unit of Use DI

[?]
Unit of Use DI Number: 00615375007501 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+18008411428
customercare@kavokerrgroup.com
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