AccessGUDID - DEVICE: KTC Burr Hole Cover (G28441001)

GUDID

Device Identifier (DI) Information

Brand Name: KTC Burr Hole Cover
Version or Model: 410-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Neurovention LLC

Primary DI Number: G28441001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 074912476 *Terms of Use

Device Description: The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery. KTC 3-piece plate is made from PEEK.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46267	Cranioplasty plate, alterable	An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material (e.g., tantalum) that can be reshaped at the time of surgery without changing the physical or chemical properties of the material. The device is generally preformed with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult skull; it is usually fixed to the intact cranial bones using screws and/or other fasteners. The device is used to repair defects due to injury, surgical intervention for tumour removal, congenital anomaly, or disease.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GXR	Cover, Burr Hole
GWO	Plate, Cranioplasty, Preformed, Alterable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192162	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6e16b093-ba85-4a7c-b9a7-0741745aeb57
Public Version Date: June 29, 2022
Public Version Number: 1
DI Record Publish Date: June 21, 2022