P-K Titanium Motility Peg System

GUDID 00854066006236

Titanium Threaded Sleeve Driver (Wrench) used with IOI's Titanium Threaded Sleeve/Flat Peg (I00045) and Titanium Large Threaded Sleeve/Flat Peg (I00100). Manual, single-use, nonsterile surgical instrument.

INTEGRATED ORBITAL IMPLANTS INC

Surgical screwdriver, reusable

• Primary Device ID: 00854066006236
• NIH Device Record Key: 965a677f-08ff-4cb4-a667-66c99cba9081
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P-K Titanium Motility Peg System
• Version Model Number: I00057
• 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: false
• 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: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com
• Phone: (858) 677-9990
• Email: haimplants@ioi.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854066006236 [Primary]

FDA Product Code

• LRZ: Screwdriver, Surgical

Sterilization

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

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

[00854066006236]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-25
• Device Publish Date: 2024-03-15

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