DEVICE: Pinnacle Temple Guard (00615375004715)

Device Identifier (DI) Information

Pinnacle Temple Guard
7300C
In Commercial Distribution

METREX RESEARCH, LLC
00615375004715
GS1

200
145963778 *Terms of Use
Panoramic HeadPositioning Guide Cover
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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?
58094 Headrest cover
A non-sterile device designed as an outer covering and used for the protection of a headrest against unhygienic conditions and helps prevent the occurrence of gross soiling. It will typically be made of thin, shaped, plastic/textile material which creates a physical barrier between the patient's head and the head supporting device. 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

c5742b47-3756-4456-9027-d05388613fa7
March 29, 2018
2
August 31, 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
HIBCC D68373001
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Unit of Use DI

[?]
Unit of Use DI Number: 00615375007471 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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