ASY-00577

GUDID 00810004729841

Dilator Holder

Integrity Implants Inc.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00810004729841
• NIH Device Record Key: 64d7c93d-7418-4331-a409-e3817b517f6a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ASY-00577
• Catalog Number: ASY-00577
• 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: true
• 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: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com
• Phone: 800.201.9300
• Email: customerservice@integrityimplants.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810004729841 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00810004729841]

Moist Heat or Steam Sterilization

[00810004729841]

Moist Heat or Steam Sterilization

[00810004729841]

Moist Heat or Steam Sterilization

[00810004729841]

Moist Heat or Steam Sterilization

[00810004729841]

Moist Heat or Steam Sterilization

[00810004729841]

Moist Heat or Steam Sterilization

[00810004729841]

Moist Heat or Steam Sterilization

[00810004729841]

Moist Heat or Steam Sterilization

[00810004729841]

Moist Heat or Steam Sterilization

[00810004729841]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-11
• Device Publish Date: 2022-10-03

Devices Manufactured by Integrity Implants Inc.

• 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
• 00840200410083 - N/A: 2024-07-18 SS Left Blade, 80mm
• 00840200410090 - N/A: 2024-07-18 SS Left Blade, 70mm
• 00840200410106 - N/A: 2024-07-18 SS Left Blade, 60mm
• 00840200410113 - N/A: 2024-07-18 SS Left Blade, 50mm