AccessGUDID - DEVICE: Innovasis® Cranial System (M711C5SD160050)

GUDID

Device Identifier (DI) Information

Brand Name: Innovasis® Cranial System
Version or Model: C5SD16005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C5SD16005
Company Name: Innovasis, Inc.

Primary DI Number: M711C5SD160050
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 156567492 *Terms of Use

Device Description: Ti 6Al 4V (ELI)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
46879	Cranioplasty plate screw	A small, threaded rod with a slotted head designed to fasten skull plates (i.e., plates with a central convex curvature matching the curvature of the forehead, side, or rear areas of the human adult) to the intact cranial bones. It is typically made of metal [e.g., stainless steel, titanium (Ti)] and has a length and diameter appropriate to match the plate holes and the cranial bones. It is used mainly in neurosurgical procedures intended to fix cranioplasty plates used to repair defects created or caused by injury, surgical intervention for tumour removal, or congenital anomaly or disease.	Obsolete	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141644	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
Length: 5 Millimeter
Outer Diameter: 1.6 Millimeter

Device Record Status

Public Device Record Key: da2ad607-1c6b-4686-9ff3-0696027fbf15
Public Version Date: February 19, 2024
Public Version Number: 4
DI Record Publish Date: December 29, 2014