ASY-00824

GUDID 00840200404464

Graft Tamp

Integrity Implants Inc.

Surgical tamp, reusable

• Primary Device ID: 00840200404464
• NIH Device Record Key: 14cecd1e-2033-4ec0-8f5b-98452580adc0
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: ASY-00824
• Catalog Number: ASY-00824
• Company DUNS: 080300717
• Company Name: Integrity 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: 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
• 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	00840200404464 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213355

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00840200404464]

Moist Heat or Steam Sterilization

[00840200404464]

Moist Heat or Steam Sterilization

[00840200404464]

Moist Heat or Steam Sterilization

[00840200404464]

Moist Heat or Steam Sterilization

[00840200404464]

Moist Heat or Steam Sterilization

[00840200404464]

Moist Heat or Steam Sterilization

[00840200404464]

Moist Heat or Steam Sterilization

[00840200404464]

Moist Heat or Steam Sterilization

[00840200404464]

Moist Heat or Steam Sterilization

[00840200404464]

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.

• 00840200409780 - NA: 2025-04-16 Adjustable Depth Stop, Tall, FH7 MIS2
• 00840200409797 - N/A: 2025-04-16 Short Cannula Body, FH7 MIS2
• 00840200409803 - N/A: 2025-04-16 Tall Cannula Body, FH7 MIS2
• 00840200409827 - NA: 2025-04-16 Dilator Handle, FH7 MIS2
• 00840200409858 - N/A: 2025-04-16 Articulating Curette, FH7 MIS2
• 00840200409872 - NA: 2025-04-16 7mm Open Shaver, FH7 MIS2
• 00840200409889 - NA: 2025-04-16 8mm Open Shaver, FH7 MIS2
• 00840200409896 - NA: 2025-04-16 9mm Open Shaver, FH7 MIS2