DEVICE: Burr Hole Cover (00855547005205)

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Device Identifier (DI) Information

Burr Hole Cover
8110

Neuropace, Inc.
00855547005205
GS1
1
The Burr Hole Cover package contains 1 Burr Hole Cover.
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Device Characteristics

MR Safe
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Cranial bur hole cover A sterile device used to cover or to plug holes drilled into the skull during surgery and to reattach cranial bone removed during the intervention. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
GXR COVER, BURR HOLE
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -34 and 57 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Compatible with a 1.3 mm lead. Requires three 1.5 to 1.8 mm bone screws.
Outer Diameter: 14 Millimeter
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Device Status

In Commercial Distribution
August 23, 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(866)726-3876
customerservice@neuropace.com
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