DEVICE: Burr Hole Cover (00855547005205)
Device Identifier (DI) Information
Burr Hole Cover
8110
In Commercial Distribution
Neuropace, Inc.
8110
In Commercial Distribution
Neuropace, Inc.
The Burr Hole Cover package contains 1 Burr Hole Cover.
Device Characteristics
MR Safe | |
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? |
---|---|---|---|---|
15749 | 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.
|
Obsolete | false |
46642 | Craniofacial fixation plate, non-bioabsorbable, non-customized |
A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, cover a burr hole and/or position/stabilize a prosthesis. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be packaged with the plate.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GXR | COVER, BURR HOLE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -34 and 57 Degrees Celsius |
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 |
Device Record Status
dbf4325a-4fb3-415d-a652-ede286b8a71a
June 09, 2025
6
August 23, 2016
June 09, 2025
6
August 23, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(866)726-3876
customerservice@neuropace.com
customerservice@neuropace.com