Biomet® Series A™ 32-486548

GUDID 00887868495076

Biomet Orthopedics, LLC

Patella prosthesis trial

• Primary Device ID: 00887868495076
• NIH Device Record Key: e3cb2395-9da0-4385-ac08-df583930bd39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biomet® Series A™
• Version Model Number: 32-486548
• Catalog Number: 32-486548
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868495076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110362

FDA Product Code

• MBV: Prosthesis, knee, patello/femorotibial, semi-constrained, uhmwpe, pegged, cemented, polymer/metal/polymer

Sterilization

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

[00887868495076]

Moist Heat or Steam Sterilization

[00887868495076]

Moist Heat or Steam Sterilization

[00887868495076]

Moist Heat or Steam Sterilization

[00887868495076]

Moist Heat or Steam Sterilization

[00887868495076]

Moist Heat or Steam Sterilization

[00887868495076]

Moist Heat or Steam Sterilization

[00887868495076]

Moist Heat or Steam Sterilization

[00887868495076]

Moist Heat or Steam Sterilization

[00887868495076]

Moist Heat or Steam Sterilization

[00887868495076]

Moist Heat or Steam Sterilization

[00887868495076]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-28
• Device Publish Date: 2022-03-19

On-Brand Devices [Biomet® Series A™]

• 00887868495076: 32-486548
• 00887868495069: 32-486547
• 00887868495052: 32-486546
• 00887868495045: 32-486545
• 00887868495038: 32-486544
• 00887868495021: 32-486543
• 00887868495014: 32-486542
• 00887868495007: 32-486541
• 00887868494994: 32-486540
• 00887868493454: 32-484784
• 00887868493423: 32-484770
• 00887868493478: 32-484788
• 00887868493461: 32-484786
• 00887868493447: 32-484782
• 00887868493430: 32-484780
• 00887868493416: 32-484768
• 00887868493409: 32-484766
• 00887868493393: 32-484764
• 00887868493386: 32-484762
• 00887868493379: 32-484760
• 00887868493362: 32-484728
• 00887868493355: 32-484726
• 00887868493348: 32-484724
• 00887868493331: 32-484722
• 00887868493324: 32-484720
• 00887868493317: 32-484710
• 00887868493300: 32-484708
• 00887868493294: 32-484706
• 00887868493287: 32-484704
• 00887868493270: 32-484702
• 00887868493263: 32-484700