151-13-29

GUDID 10885862029980

MILL GUIDE, METAPHYSEAL, 29mm

Exactech, Inc.

Orthopaedic reamer guide

• Primary Device ID: 10885862029980
• NIH Device Record Key: 98ec8f75-b4eb-4506-9556-7be2f1adfa9f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 151-13-29
• Catalog Number: 151-13-29
• 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 Dimensions

• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 29 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862029980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010120

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

[10885862029980]

Moist Heat or Steam Sterilization

[10885862029980]

Moist Heat or Steam Sterilization

[10885862029980]

Moist Heat or Steam Sterilization

[10885862029980]

Moist Heat or Steam Sterilization

[10885862029980]

Moist Heat or Steam Sterilization

[10885862029980]

Moist Heat or Steam Sterilization

[10885862029980]

Moist Heat or Steam Sterilization

[10885862029980]

Moist Heat or Steam Sterilization

[10885862029980]

Moist Heat or Steam Sterilization

[10885862029980]

Moist Heat or Steam Sterilization

[10885862029980]

Moist Heat or Steam Sterilization

[10885862029980]

Moist Heat or Steam Sterilization

[10885862029980]

Moist Heat or Steam Sterilization

[10885862029980]

Moist Heat or Steam Sterilization

[10885862029980]

Moist Heat or Steam Sterilization

[10885862029980]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-02
• Device Publish Date: 2022-08-25

Devices Manufactured by Exactech, Inc.

• 10885862653109 - Alteon: 2024-12-02 Special Anterior Approach Cip Impactor Alignment Guide
• 10885862654793 - Equinoxe: 2024-12-02 Ergo GPS 3.2mm Drill Guide
• 10885862607324 - TRULIANT®: 2024-11-18 Porous Tibial Tray with Screw Holes
• 10885862607331 - TRULIANT®: 2024-11-18 Porous Tibial Tray with Screw Holes
• 10885862607348 - TRULIANT®: 2024-11-18 Porous Tibial Tray with Screw Holes
• 10885862607355 - TRULIANT®: 2024-11-18 Porous Tibial Tray with Screw Holes
• 10885862607362 - TRULIANT®: 2024-11-18 Porous Tibial Tray with Screw Holes
• 10885862607379 - TRULIANT®: 2024-11-18 Porous Tibial Tray with Screw Holes