AccessGUDID - DEVICE: Burr Hole Cover (00855547005205)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00855547005205
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 123369238 *Terms of Use

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

Device Characteristics

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

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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.

FDA Product Code

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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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

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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

Public Device Record Key: dbf4325a-4fb3-415d-a652-ede286b8a71a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 23, 2016