Optetrak SPI-003325

GUDID 10885862630360

ARC Guide Sliding Stylus

Exactech, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 10885862630360
• NIH Device Record Key: df5755f4-2474-4a95-ac5a-5106dc596d25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optetrak
• Version Model Number: SPI-003325
• Catalog Number: SPI-003325
• Company DUNS: 157565946
• Company Name: Exactech, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862630360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011976

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

[10885862630360]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-23
• Device Publish Date: 2023-08-15