101-05-07

GUDID 10885862010582

MODULAR DRILL BIT, 4.5mm x 67mm X-LONG

Exactech, Inc.

Fluted surgical drill bit, reusable

• Primary Device ID: 10885862010582
• NIH Device Record Key: 5d5d02a6-4cbb-4c9a-b5a5-691c655c39c1
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 101-05-07
• Catalog Number: 101-05-07
• 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

• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 67 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 67 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 67 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 67 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 67 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 67 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 67 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 67 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 67 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 67 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 67 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 67 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 67 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Length: 67 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862010582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141797

FDA Product Code

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

Sterilization

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

[10885862010582]

Moist Heat or Steam Sterilization

[10885862010582]

Moist Heat or Steam Sterilization

[10885862010582]

Moist Heat or Steam Sterilization

[10885862010582]

Moist Heat or Steam Sterilization

[10885862010582]

Moist Heat or Steam Sterilization

[10885862010582]

Moist Heat or Steam Sterilization

[10885862010582]

Moist Heat or Steam Sterilization

[10885862010582]

Moist Heat or Steam Sterilization

[10885862010582]

Moist Heat or Steam Sterilization

[10885862010582]

Moist Heat or Steam Sterilization

[10885862010582]

Moist Heat or Steam Sterilization

[10885862010582]

Moist Heat or Steam Sterilization

[10885862010582]

Moist Heat or Steam Sterilization

[10885862010582]

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

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