AccessGUDID - DEVICE: Burr Hole Cover (00855547005205)

GUDID

Brand Name: Burr Hole Cover
Version or Model: 8110
Catalog Number:
Company Name: Neuropace, Inc.

Primary DI Number: 00855547005205
Issuing Agency: GS1
Device Count: 1

Device Description: The Burr Hole Cover package contains 1 Burr Hole Cover.

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

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.

Product Code	Product Code Name
GXR	COVER, BURR HOLE

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling
Storage Environment Temperature: between -34 and 57 Degrees Celsius

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

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: August 23, 2016
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Device Subject to Direct Marking (DM), but Exempt: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Phone: +1(866)726-3876
Email: customerservice@neuropace.com