Optetrak SPI-009086

GUDID 10885862634993

Special Double End Patellar Drill Guide, 32/35mm

Exactech, Inc.

Surgical drill guide, reusable

• Primary Device ID: 10885862634993
• NIH Device Record Key: a9acff12-e919-40a5-9ac9-2bc5569530a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optetrak
• Version Model Number: SPI-009086
• Catalog Number: SPI-009086
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	10885862634993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932690

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[10885862634993]

Moist Heat or Steam Sterilization

[10885862634993]

Moist Heat or Steam Sterilization

[10885862634993]

Moist Heat or Steam Sterilization

[10885862634993]

Moist Heat or Steam Sterilization

[10885862634993]

Moist Heat or Steam Sterilization

[10885862634993]

Moist Heat or Steam Sterilization

[10885862634993]

Moist Heat or Steam Sterilization

[10885862634993]

Moist Heat or Steam Sterilization

[10885862634993]

Moist Heat or Steam Sterilization

[10885862634993]

Moist Heat or Steam Sterilization

[10885862634993]

Moist Heat or Steam Sterilization

[10885862634993]

Moist Heat or Steam Sterilization

[10885862634993]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-21
• Device Publish Date: 2024-03-13