P-K Titanium Motility Peg System

GUDID 00854066006175

INTEGRATED ORBITAL IMPLANTS INC

Ocular peg/screw system

• Primary Device ID: 00854066006175
• NIH Device Record Key: 106d4f66-75e2-4b7f-903a-7f77e67eecd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P-K Titanium Motility Peg System
• Version Model Number: I00100
• Company DUNS: 859186348
• Company Name: INTEGRATED ORBITAL IMPLANTS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-424-6537
• Email: haimplants@ioi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854066006175 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974203

FDA Product Code

• MQU: Ocular Peg

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00854066006175]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-12-01

On-Brand Devices [P-K Titanium Motility Peg System]

• 00854066006212: I00089
• 00854066006205: I00087
• 00854066006199: I00051
• 00854066006182: I00049
• 00854066006175: I00100
• 00854066006168: I00045
• 00854066006236: Titanium Threaded Sleeve Driver (Wrench) used with IOI's Titanium Threaded Sleeve/Flat Peg (I000