AccessGUDID - DEVICE: Innovasis® Cranial System (M711C2ST160120)

GUDID

Device Identifier (DI) Information

Brand Name: Innovasis® Cranial System
Version or Model: C2ST16012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C2ST16012
Company Name: Innovasis, Inc.

Primary DI Number: M711C2ST160120
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 156567492 *Terms of Use

Device Description: CP Ti

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?
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
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
No Device Sizes

Device Record Status

Public Device Record Key: e75e9b89-9aa5-413f-b59f-df85ea7c7d4a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 29, 2014