EPIC SNAP-OFF SCREW 4000-0011

GUDID 00817577023154

Exactech, Inc.

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00817577023154
• NIH Device Record Key: a5ff3f30-6e7a-47c6-bc61-bccbd13efc8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EPIC SNAP-OFF SCREW
• Version Model Number: 4000-0011
• Catalog Number: 4000-0011
• 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: 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817577023154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163038

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[00817577023154]

Moist Heat or Steam Sterilization

[00817577023154]

Moist Heat or Steam Sterilization

[00817577023154]

Moist Heat or Steam Sterilization

[00817577023154]

Moist Heat or Steam Sterilization

[00817577023154]

Moist Heat or Steam Sterilization

[00817577023154]

Moist Heat or Steam Sterilization

[00817577023154]

Moist Heat or Steam Sterilization

[00817577023154]

Moist Heat or Steam Sterilization

[00817577023154]

Moist Heat or Steam Sterilization

[00817577023154]

Moist Heat or Steam Sterilization

[00817577023154]

Moist Heat or Steam Sterilization

[00817577023154]

Moist Heat or Steam Sterilization

[00817577023154]

Moist Heat or Steam Sterilization

[00817577023154]

Moist Heat or Steam Sterilization

[00817577023154]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-23
• Device Publish Date: 2020-10-15

On-Brand Devices [EPIC SNAP-OFF SCREW]

• 00817577023185: 4000-0014
• 00817577023178: 4000-0013
• 00817577023161: 4000-0012
• 00817577023154: 4000-0011