PECTUS SYSTEMPS-0820

GUDID 00841036214876

BIOMET MICROFIXATION, INC

Funnel chest remodelling bar

• Primary Device ID: 00841036214876
• NIH Device Record Key: db7f2bcd-a480-40f4-9f37-f6fe5b93683a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PECTUS SYSTEMPS-0820
• Version Model Number: PS-0815
• 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: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM
• Phone: 904-741-4400
• Email: FXJAX-ORDERS@BIOMET.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036214876 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061384

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00841036214876]

Moist Heat or Steam Sterilization

[00841036214876]

Moist Heat or Steam Sterilization

[00841036214876]

Moist Heat or Steam Sterilization

[00841036214876]

Moist Heat or Steam Sterilization

[00841036214876]

Moist Heat or Steam Sterilization

[00841036214876]

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: 2016-06-22

On-Brand Devices [PECTUS SYSTEMPS-0820]

• 00841036214883: PS-0816
• 00841036214876: PS-0815
• 00841036214821: PS-0824
• 00841036214814: PS-0821