101-05-01

GUDID 10885862010537

Drill Bit, 3.2mm x 32 mm, Short

Exactech, Inc.

Fluted surgical drill bit, single-use

• Primary Device ID: 10885862010537
• NIH Device Record Key: a01d575f-a546-4ba5-9092-97e6991a633c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 101-05-01
• Catalog Number: 101-05-01
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862010537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141797

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

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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