EPIC SMALL STAPLE 3100-0000

GUDID 00817577023192

Small Staple Instrument

Exactech, Inc.

Orthopaedic bone staple driver Orthopaedic bone staple driver

• Primary Device ID: 00817577023192
• NIH Device Record Key: 0647eac6-58df-49c6-907a-9de34a06ad3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIC SMALL STAPLE
• Version Model Number: A
• Catalog Number: 3100-0000
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00817577023192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163226

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

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

[00817577023192]

Moist Heat or Steam Sterilization

[00817577023192]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-17
• Device Publish Date: 2018-10-31

On-Brand Devices [EPIC SMALL STAPLE]

• 00817577023192: Small Staple Instrument
• 00817577023147: Small Staple