101-05-02

GUDID 10885862010544

Drill Bit, 3.2mm x 50 mm, Long

Exactech, Inc.

Fluted surgical drill bit, single-use

• Primary Device ID: 10885862010544
• NIH Device Record Key: 4313df79-6aba-4c13-8a1f-058db887091f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 101-05-02
• Catalog Number: 101-05-02
• 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

• Device Size Text, specify: 0
• Outer Diameter: 3.2 Millimeter
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.2 Millimeter
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.2 Millimeter
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.2 Millimeter
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.2 Millimeter
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.2 Millimeter
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.2 Millimeter
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.2 Millimeter
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.2 Millimeter
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.2 Millimeter
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.2 Millimeter
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.2 Millimeter
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.2 Millimeter
• Length: 50 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 3.2 Millimeter
• Length: 50 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862010544 [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: 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

Devices Manufactured by Exactech, Inc.

• 10885862657046 - CSB: 2026-02-05 CSB Cage Drill Pilot Tip, 0°
• 10885862657053 - CSB: 2026-02-05 CSB Cage Drill Pilot Tip 8°, 10°, 8°/10°
• 10885862657060 - CSB: 2026-02-05 CSB Non-Tapered Hex Driver
• 10885862657237 - CSB: 2026-02-05 CSB Drill Bushing
• 10885862658159 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 22mm O.D., +0, 12/14
• 10885862658166 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 22mm O.D., +3, 12/14
• 10885862658173 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 22mm O.D., +7, 12/14
• 10885862658180 - EXACTECH: 2025-11-24 EXACTECH® CoCr FEM HEAD, 22mm O.D., +10, 12/14