Plastic Drawing Guide

Basic Information

• Brand Name: Plastic Drawing Guide
• Primary DI: 07350086550528
• Version / Model: S
• Company Name: Ossdsign AB
• Labeler DUNS: 350354370
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-22
• Public Version: 3
• Public Version Date: 2024-02-06
• Public Version Status: Update
• Public Device Record Key: 56dfc869-a2cc-4cd4-9c3f-a4080a5ccf37
• Distribution End Date: 2023-11-30

Device Description

OSSDSIGN Cranial PSI Accessories are optional devices that support physician use of the OSSDSIGN Cranial PSI (K161090) parent device. They are additively manufactured from PA2200 polyamide material. Each Cranial PSI Accessory is patient-specific and corresponds to a patient’s unique anatomical requirements. Cranial PSI Accessories are intended to support implantation of the corresponding Cranial PSI parent device; both devices are designed from the same patient-specific computed tomography image data set. (510(k) no. K190523)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PJN	Filler, Bone Void, Non-Alterable Compound For Cranioplasty	Neurology	882.5330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62249	Custom-made organ/bone anatomy model/surgical guide kit	A collection of custom-made devices intended to be used to assist anatomical visualization, surgical treatment planning, and intraoperative surgical procedures (e.g., orientation of implant components, guiding of surgical instruments). It consists of an anatomy model(s) of an organ/bone and an orthopaedic/craniomaxillofacial surgical guide(s) [e.g., for osteotomy, arthroplasty]; it is made of synthetic polymer materials and is manufactured by 3-D printing and CAD/CAM techniques to match the patient-specific contours of the target anatomical site. This is a single-use device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	17350086550525	GS1	box	1	Not in Commercial Distribution	2023-11-30
Primary	07350086550528	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 34 Degrees Celsius