INVISx®

Basic Information

• Brand Name: INVISx®
• Primary DI: 20643169466306
• Version / Model: 60100
• Company Name: MEDTRONIC PS MEDICAL, INC.
• Labeler DUNS: 089055867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2015-07-16
• Public Version: 5
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: c4e5d2bd-63fa-4a95-98a9-9ba031989b72

Device Description

LOCKS 60100 INVISX 2PK CE

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GXN	PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE	Neurology	882.5330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56730	Cranial bone flap fixation clip	A sterile, non-metallic, non-bioabsorbable device designed to be partially implanted around the perimeter of a replaced cranial bone flap after a craniotomy to ensure structural stability during the healing period. It is typically made of biocompatible plastic materials [e.g., polyoxymethylene (POM), commonly known as Delrin] and is typically designed with internal and external flanges that are tensioned together over the bone of both the flap and skull and locked via a central stem. It may also be used for craniofacial bone fracture fixation. Its non-metallic design makes it more compatible with radiological imaging than metallic clips.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20643169466306	GS1
Unit of Use	00643169466302	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K010361	000

Device Sizes

Type	Value	Unit	Text
Width	2.54	Millimeter