161-00-30

GUDID 10885862033390

GUIDE TIP, CALCAR PLANER

Exactech, Inc.

Bone-resection orthopaedic reamer, reusable

• Primary Device ID: 10885862033390
• NIH Device Record Key: 7b2b4daf-aa28-47e2-970f-c7e473a5c7c2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 161-00-30
• Catalog Number: 161-00-30
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862033390 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042842

FDA Product Code

• LWJ: Prosthesis, hip, semi-constrained, metal/polymer, uncemented

Sterilization

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

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

[10885862033390]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-05
• Device Publish Date: 2022-07-28

Devices Manufactured by Exactech, Inc.

• 10885862083852 - Equinoxe: 2025-03-06
• 10885862083869 - Equinoxe: 2025-03-06
• 10885862083876 - Equinoxe: 2025-03-06
• 10885862083883 - Equinoxe: 2025-03-06
• 10885862083890 - Equinoxe: 2025-03-06
• 10885862083906 - Equinoxe: 2025-03-06
• 10885862083913 - Equinoxe: 2025-03-06
• 10885862083920 - Equinoxe: 2025-03-06