Accelus Navigated Reusable Instruments ASY-00742

GUDID 00810045535029

Nav 7.5mm Cannulated Dual Lead Tap

INTEGRITY IMPLANTS INC.

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• Primary Device ID: 00810045535029
• NIH Device Record Key: 3225f110-c3e5-480c-854a-55b03ff4bd9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accelus Navigated Reusable Instruments
• Version Model Number: ASY-00742
• Catalog Number: ASY-00742
• 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: 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
• 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
• 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
• 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	00810045535029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212088

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

[00810045535029]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-14
• Device Publish Date: 2022-03-04

On-Brand Devices [Accelus Navigated Reusable Instruments]

• 00840200404174: 4.0mm Cannulated Dual Lead Nav Tap
• 00840200404143: Nav Probe Duck Billed Straight
• 00840200404099: Nav Probe Straight
• 00840200404082: Nav Bone Awl
• 00840200404075: 5.5-6.0mm Polyaxial Nav Screw Driver
• 00810045535043: Nav 4.0mm Dual Lead Tap
• 00810045535036: Nav 8.5mm Cannulated Dual Lead Tap
• 00810045535029: Nav 7.5mm Cannulated Dual Lead Tap
• 00810045535012: Nav 6.5mm Cannulated Dual Lead Tap
• 00810045535005: Nav 5.5mm Cannulated Dual Lead Tap
• 00810045534992: Nav 5.0mm Cannulated Dual Lead Tap
• 00810045534985: Nav 4.5mm Cannulated Dual Lead Tap
• 00810045534978: Nav 8.5 mm Quad Lead Tap
• 00810045534961: Nav 7.5 mm Quad Lead Tap
• 00810045534954: Nav 6.5 mm Quad Lead Tap
• 00810045534947: Nav 5.5 mm Quad Lead Tap
• 00810045534930: Nav 5.0 mm Quad Lead Tap
• 00810045534923: Nav 4.5 mm Quad Lead Tap
• 00810045534916: Nav 4.0 mm Quad Lead Tap
• 00810045534558: Nav 4.5mm Dual Lead Tap
• 00810045534541: Nav 5.0mm Dual Lead Tap
• 00810045534534: Nav 5.5mm Dual Lead Tap
• 00810045534527: Nav 6.5mm Dual Lead Tap
• 00810045534510: Nav 7.5mm Dual Lead Tap
• 00810045534503: Nav 8.5mm Dual Lead Tap
• 00810045534497: Nav 9.5mm Dual Lead Tap
• 00810045534480: Nav 10.5mm Dual Lead Tap
• 00810045534473: Nav Modular Shank Driver - SM Ball
• 00810045534466: 5.5-6.0mm Polyaxial MG Nav Screw Driver