BIOMET SERIES A 32-484700

GUDID 00880304437944

Biomet Orthopedics, LLC

Patella prosthesis trial

• Primary Device ID: 00880304437944
• NIH Device Record Key: e8f943a3-a5c8-458c-aba7-a171f790868d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOMET SERIES A
• Version Model Number: 32-484700
• Catalog Number: 32-484700
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• 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: false
• 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(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304437944 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113550

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

[00880304437944]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-22

On-Brand Devices [BIOMET SERIES A]

• 00880304438088: 32-484720
• 00880304438071: 32-484724
• 00880304438064: 32-484704
• 00880304438057: 32-484706
• 00880304438040: 32-484708
• 00880304438033: 32-484726
• 00880304438026: 32-484788
• 00880304438019: 32-484786
• 00880304438002: 32-484770
• 00880304437999: 32-484768
• 00880304437982: 32-484766
• 00880304437975: 32-484764
• 00880304437968: 32-484762
• 00880304437951: 32-484760
• 00880304437944: 32-484700
• 00880304437920: 32-484722
• 00880304437913: 32-484728
• 00880304437906: 32-484780
• 00880304437890: 32-484710
• 00880304437722: 32-484782
• 00880304437623: 32-484784