121-01-00

GUDID 10885862020352

IMPACTOR, CUP, STRAIGHT

Exactech, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 10885862020352
• NIH Device Record Key: f9fb3ccb-85b8-499e-b1ae-95040612b89f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 121-01-00
• Catalog Number: 121-01-00
• 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	10885862020352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070479

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

[10885862020352]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-26
• Device Publish Date: 2022-08-18

Devices Manufactured by Exactech, Inc.

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• 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