251-06-00

GUDID 10885862065506

COLLARED DRILL BIT, .2280", WITH STOP

Exactech, Inc.

Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable

• Primary Device ID: 10885862065506
• NIH Device Record Key: c773a7bf-c1c8-4078-95f4-4fcb54b64a30
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 251-06-00
• Catalog Number: 251-06-00
• 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 Dimensions

• Outer Diameter: 0.228 Inch
• Outer Diameter: 0.228 Inch
• Outer Diameter: 0.228 Inch
• Outer Diameter: 0.228 Inch
• Outer Diameter: 0.228 Inch
• Outer Diameter: 0.228 Inch
• Outer Diameter: 0.228 Inch
• Outer Diameter: 0.228 Inch
• Outer Diameter: 0.228 Inch
• Outer Diameter: 0.228 Inch
• Outer Diameter: 0.228 Inch
• Outer Diameter: 0.228 Inch
• Outer Diameter: 0.228 Inch
• Outer Diameter: 0.228 Inch
• Outer Diameter: 0.228 Inch
• Outer Diameter: 0.228 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862065506 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040889

FDA Product Code

• HRY: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[10885862065506]

Moist Heat or Steam Sterilization

[10885862065506]

Moist Heat or Steam Sterilization

[10885862065506]

Moist Heat or Steam Sterilization

[10885862065506]

Moist Heat or Steam Sterilization

[10885862065506]

Moist Heat or Steam Sterilization

[10885862065506]

Moist Heat or Steam Sterilization

[10885862065506]

Moist Heat or Steam Sterilization

[10885862065506]

Moist Heat or Steam Sterilization

[10885862065506]

Moist Heat or Steam Sterilization

[10885862065506]

Moist Heat or Steam Sterilization

[10885862065506]

Moist Heat or Steam Sterilization

[10885862065506]

Moist Heat or Steam Sterilization

[10885862065506]

Moist Heat or Steam Sterilization

[10885862065506]

Moist Heat or Steam Sterilization

[10885862065506]

Moist Heat or Steam Sterilization

[10885862065506]

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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• 10885862635044 - Equinoxe: 2024-07-16 Special Small Spiked Humeral Resection Cover
• 10885862635051 - Equinoxe: 2024-07-16 Special Medium Spiked Humeral Resection Cover
• 10885862635068 - Equinoxe: 2024-07-16 Special Large Spiked Humeral Resection Cover
• 10885862635143 - Equinoxe: 2024-07-16 Special Laser Cage Trephine Drill. 0-8 Deg, Peripheral Pegs
• 10885862635150 - Equinoxe: 2024-07-16 Special Laser Cage Trephone Drill. 0-8 Deg, Central Cage
• 10885862630704 - Equinoxe: 2024-06-20 Special Modular rTSA 32mm Circular Reamer