CMP-02850

GUDID 00840200410168

Dilator 3

Integrity Implants Inc.

Endoscopic-access dilator, reusable

• Primary Device ID: 00840200410168
• NIH Device Record Key: bca1ff50-3bb1-4cef-8000-920192dd8b3b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CMP-02850
• Catalog Number: CMP-02850
• Company DUNS: 080300717
• Company Name: Integrity Implants 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: 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: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com
• Phone: 8002019300
• Email: customerservice@integrityimplants.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840200410168 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00840200410168]

Moist Heat or Steam Sterilization

[00840200410168]

Moist Heat or Steam Sterilization

[00840200410168]

Moist Heat or Steam Sterilization

[00840200410168]

Moist Heat or Steam Sterilization

[00840200410168]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-18
• Device Publish Date: 2024-07-10

Devices Manufactured by Integrity Implants Inc.

• 00840200410229 - NA: 2024-10-28 5.5-6.0 MIS Counter Torque - No Lip
• 00840200402477 - LineSider: 2024-10-25 5.5/6.0mm, Non-mod Standard 7.1mm- Iliac Shank - 9.5mm x 90mm
• 00840200407373 - N/A: 2024-10-25 Open Disc Prep Insert 2
• 00840200405492 - NA: 2024-09-09 BH Tapered Screw Starter
• 00840200410045 - N/A: 2024-07-18 SS Right Blade, 80mm
• 00840200410052 - N/A: 2024-07-18 SS Right Blade, 70mm
• 00840200410069 - N/A: 2024-07-18 SS Right Blade, 60mm
• 00840200410076 - N/A: 2024-07-18 SS Right Blade, 50mm