Paragon Hip System XH-61115

GUDID 00841690184997

Paragon CALCAR PLANER - LARGE

Omni Life Science, Inc.

Bone-resection orthopaedic reamer, reusable

• Primary Device ID: 00841690184997
• NIH Device Record Key: 6eb64f26-5bc4-43e9-81d6-ab7ff0da1ecc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paragon Hip System
• Version Model Number: XH-61115
• Catalog Number: XH-61115
• Company DUNS: 061339651
• Company Name: Omni Life Science, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com
• Phone: +1(800)448-6664
• Email: CS@omnils.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841690184997 [Primary]

FDA Product Code

• HWE: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Sterilization

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

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

[00841690184997]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-13
• Device Publish Date: 2023-01-10

On-Brand Devices [Paragon Hip System]

• 00841690185017: Paragon CALCAR PLANER - SMALL
• 00841690185000: Paragon CALCAR PLANER - MEDIUM
• 00841690184997: Paragon CALCAR PLANER - LARGE