FDA.reportPublic FDA data

Burr Hole Cover

Primary DI
00855547005205
Brand
Burr Hole Cover
Company
Neuropace, Inc.
Model
8110
Device description
The Burr Hole Cover package contains 1 Burr Hole Cover.
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXRCOVER, BURR HOLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXRCover, Burr HoleNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855547005205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855547005205008555470052058555470052050855547005205

GMDN Terms#

Term, Definition table
TermDefinition
Cranial bur hole coverA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter14Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-34 Degrees Celsius57 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)726-3876customerservice@neuropace.com

Regulatory Flags#

DUNS number
123369238
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00855547005427NeuroPace® Remote Monitor Kit51072023-11-14
00855547005434NeuroPace® Remote Monitor Kit51072023-11-14
00855547005281RNS® Tablet Kit50012018-01-15
00855547005007NeuroPace® Patient Data Management System (PDMS)Model 43402015-07-22
00855547005366RNS® Neurostimulator KitRNS-320-K2020-03-10
00855547005410Explant KitEX-01-K2022-02-22
00855547005137MagnetM-012014-09-24
00855547005403Remote Monitor Phone Accessories51042020-09-14
00855547005250NeuroPace® Remote Monitor Kit51012018-05-18
00855547005113WandW-022014-09-24
00855547005120RNS® Neurostimulator KitRNS-300M-K2017-12-18
00855547005267RNS® Neurostimulator KitRNS-320-K2018-05-18
00855547005373Ferrule KitF-01-K2020-03-16
00855547005380Craniectomy Template KitCT-01-K2020-03-16
00855547005397Connector Cover KitCC-01-K2020-03-16
00855547005298NeuroPace® Depth Lead KitDL-344-10-K2020-03-15
00855547005304NeuroPace® Cortical Strip Lead KitCL-335-10-K2020-03-15
00855547005311NeuroPace® Cortical Strip Lead KitCL-325-10-K2020-03-15
00855547005328NeuroPace® Cortical Strip Lead KitCL-315-10-K2020-03-15
00855547005335NeuroPace® Depth Lead KitDL-330-10-K2020-03-15

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