131-01-01

GUDID 10885862022424

Liner Inserter Handle

Exactech, Inc.

Orthopaedic implant impactor

• Primary Device ID: 10885862022424
• NIH Device Record Key: 111cbd91-2dd2-41c2-8048-f613b2443b64
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 131-01-01
• Catalog Number: 131-01-01
• 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	10885862022424 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173583

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

[10885862022424]

Moist Heat or Steam Sterilization

[10885862022424]

Moist Heat or Steam Sterilization

[10885862022424]

Moist Heat or Steam Sterilization

[10885862022424]

Moist Heat or Steam Sterilization

[10885862022424]

Moist Heat or Steam Sterilization

[10885862022424]

Moist Heat or Steam Sterilization

[10885862022424]

Moist Heat or Steam Sterilization

[10885862022424]

Moist Heat or Steam Sterilization

[10885862022424]

Moist Heat or Steam Sterilization

[10885862022424]

Moist Heat or Steam Sterilization

[10885862022424]

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.

• 10885862630377 - Equinoxe: 2024-11-06 Special Ergo Impactor Handle
• 10885862650269 - Equinoxe: 2024-11-01 Special Humeral Stem Impactor, 36mm Insert
• 10885862650276 - Equinoxe: 2024-11-01 Special Humeral Stem Impactor, 40mm Insert
• 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