THINFLAP SYSTEM 5/PK 91-6804-5PK

GUDID 00888233025317

BIOMET MICROFIXATION, INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00888233025317
• NIH Device Record Key: 6530d23f-0e10-4792-a7e0-85c651d9e0d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: THINFLAP SYSTEM 5/PK
• Version Model Number: 91-6804-5PK
• Catalog Number: 91-6804-5PK
• Company DUNS: 046189866
• Company Name: BIOMET MICROFIXATION, 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

Customer Support Contacts

• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888233025317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121589

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[00888233025317]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-19
• Device Publish Date: 2020-06-18

On-Brand Devices [THINFLAP SYSTEM 5/PK]

• 00841036190408: 91-6804-5PK
• 00841036138233: 91-6604-5PK
• 00888233025317: 91-6804-5PK
• 00888233012263: 91-6604-5PK