"1.5MM" SYSTEM BONE SCREW 01-7284

GUDID 00841036013622

BIOMET MICROFIXATION, INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841036013622
• NIH Device Record Key: 76e7a89f-5420-45b4-873c-107430719f30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: "1.5MM" SYSTEM BONE SCREW
• Version Model Number: 01-7284
• Catalog Number: 01-7284
• 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
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036013622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K013954

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00841036013622]

Moist Heat or Steam Sterilization

[00841036013622]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-11

On-Brand Devices ["1.5MM" SYSTEM BONE SCREW]

• 00841036057794: 99-7285
• 00841036057787: 99-7284
• 00841036057770: 99-7283
• 00841036013639: 01-7285
• 00841036013622: 01-7284
• 00841036013615: 01-7283