101-05-20

GUDID 10885862010636

3.2MM DRILL BIT 20MM 1PK

Exactech, Inc.

Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use

• Primary Device ID: 10885862010636
• NIH Device Record Key: 6f8e5823-ff7e-46ba-b036-59fdb8843379
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 101-05-20
• Catalog Number: 101-05-20
• 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

• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0
• Length: 20 Millimeter
• Outer Diameter: 3.2 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862010636 [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: 2022-09-02
• Device Publish Date: 2022-08-25

Devices Manufactured by Exactech, Inc.

• 10885862634931 - Accumatch: 2024-05-10 Special 3.2 mm Drill Guide
• 10885862634948 - Accumatch: 2024-05-10 Special 4.5mm Drill Guide
• 10885862595447 - Equinoxe: 2024-04-22 PHx Humeral Plate Instrument Case, Base
• 10885862595454 - Equinoxe: 2024-04-22 PHx Humeral Plate Instrument Case, Tray
• 10885862595461 - Equinoxe: 2024-04-22 PHx Humeral Plate Compression Screw Caddy
• 10885862595478 - Equinoxe: 2024-04-22 PHx Humeral Plate Locking Screw Caddy
• 10885862595485 - Equinoxe: 2024-04-22 PHx Humeral Plate 6.5mm Screw Caddy
• 10885862628947 - EXACTECHGPS: 2024-04-15 Station V3