P-K Titanium Motility Peg System

Basic Information

• Brand Name: P-K Titanium Motility Peg System
• Primary DI: 00854066006199
• Version / Model: I00051
• Company Name: INTEGRATED ORBITAL IMPLANTS INC
• Labeler DUNS: 859186348
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a5062050-a4b5-4f0b-9dc3-a5cf7c7f4482

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: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQU	Ocular Peg	Ophthalmic	886.3320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44420	Ocular peg/screw system	An assembly of devices used together with certain types of ocular rim prostheses for patients who wish to gain improved prosthetic eye motility by coupling the ocular implant to the prosthetic eye. This device will typically consist of screws made of, e.g., titanium (Ti)/stainless steel, or pegs made of, e.g., polyethylene (PE), and small magnets; included may be the tools (e.g., a screwdriver, a holding clamp, and drill bits) necessary for insertion of the screws/magnets. The magnets are embedded into the posterior of the prosthetic eye and powerful enough to provide a coupling force between the implant and the prosthesis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854066006199	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K974203	000