141-01-36

GUDID 10885862026149

LINER DRIVER HEAD, 36mm

Exactech, Inc.

Orthopaedic implant impactor

• Primary Device ID: 10885862026149
• NIH Device Record Key: 46cbffd9-6685-4bbd-8613-770dad1b3077
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 141-01-36
• Catalog Number: 141-01-36
• 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: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 36 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862026149 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173583

FDA Product Code

• OQI: Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented

Sterilization

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

[10885862026149]

Moist Heat or Steam Sterilization

[10885862026149]

Moist Heat or Steam Sterilization

[10885862026149]

Moist Heat or Steam Sterilization

[10885862026149]

Moist Heat or Steam Sterilization

[10885862026149]

Moist Heat or Steam Sterilization

[10885862026149]

Moist Heat or Steam Sterilization

[10885862026149]

Moist Heat or Steam Sterilization

[10885862026149]

Moist Heat or Steam Sterilization

[10885862026149]

Moist Heat or Steam Sterilization

[10885862026149]

Moist Heat or Steam Sterilization

[10885862026149]

Moist Heat or Steam Sterilization

[10885862026149]

Moist Heat or Steam Sterilization

[10885862026149]

Moist Heat or Steam Sterilization

[10885862026149]

Moist Heat or Steam Sterilization

[10885862026149]

Moist Heat or Steam Sterilization

[10885862026149]

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

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• 10885862631305 - ExactechGPS Ankle Application: 2024-10-28 Tibial Cut Tracker
• 10885862631312 - ExactechGPS Ankle Application: 2024-10-28 3D/3D+ Tibial Cut Tracker
• 10885862631329 - ExactechGPS Ankle Application: 2024-10-28 Talar Cut Tracker
• 10885862631336 - ExactechGPS Ankle Application: 2024-10-28 Cut Checker
• 10885862631343 - ExactechGPS Ankle Application: 2024-10-28 3D/3D+ Cut Checker