AccessGUDID - DEVICE: Integra® Compact Cranial Closure System (10381780074359)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Compact Cranial Closure System
Version or Model: CRANCLOSIMP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CRANCLOSIMP
Company Name: INTEGRA LIFESCIENCES CORPORATION

Primary DI Number: 10381780074359
Issuing Agency: GS1
Commercial Distribution End Date: September 12, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 963856096 *Terms of Use

Device Description: The Integra Compact Cranial Closer System bone plates and screws are made of pure titanium and titanium alloy with screw diameters from 1.5mm to 1.8mm and lengths from 3.0mm to 5.0mm. The system offers the operating room surgeon unique features and user friendly capabilities. This device is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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
HBW	Fastener, Plate, Cranioplasty
GXR	Cover, Burr Hole
GWO	Plate, Cranioplasty, Preformed, Alterable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112812	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
Device Size Text, specify: 10.16 in L x 4.41 in W x 2.0 in H

Device Record Status

Public Device Record Key: 4fb533c3-48f3-4bed-bd91-0a2d7d32b9da
Public Version Date: September 14, 2020
Public Version Number: 6
DI Record Publish Date: August 15, 2015