InteGrip 186-01-08

GUDID 10885862038722

Exactech, Inc.

Acetabular shell

• Primary Device ID: 10885862038722
• NIH Device Record Key: 9d17653c-6b3a-40c6-a8cb-a6e1c11fb523
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InteGrip
• Version Model Number: 186-01-08
• Catalog Number: 186-01-08
• 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: true
• 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

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• Device Size Text, specify: 0
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• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10885862038722 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101761

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-09
• Device Publish Date: 2015-10-30