OSS BOWED STEM TRIAL 110018721

GUDID 00880304679061

Biomet Orthopedics, LLC

Knee femur prosthesis trial

• Primary Device ID: 00880304679061
• NIH Device Record Key: 9e001300-27be-4ba8-a325-90bb1a71bdc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSS BOWED STEM TRIAL
• Version Model Number: 110018721
• Catalog Number: 110018721
• 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: true
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304679061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141331

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

[00880304679061]

Moist Heat or Steam Sterilization

[00880304679061]

Moist Heat or Steam Sterilization

[00880304679061]

Moist Heat or Steam Sterilization

[00880304679061]

Moist Heat or Steam Sterilization

[00880304679061]

Moist Heat or Steam Sterilization

[00880304679061]

Moist Heat or Steam Sterilization

[00880304679061]

Moist Heat or Steam Sterilization

[00880304679061]

Moist Heat or Steam Sterilization

[00880304679061]

Moist Heat or Steam Sterilization

[00880304679061]

Moist Heat or Steam Sterilization

[00880304679061]

Moist Heat or Steam Sterilization

[00880304679061]

Moist Heat or Steam Sterilization

[00880304679061]

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: 2016-10-27

On-Brand Devices [OSS BOWED STEM TRIAL]

• 00880304679160: 110018731
• 00880304679153: 110018730
• 00880304679146: 110018729
• 00880304679139: 110018728
• 00880304679122: 110018727
• 00880304679115: 110018726
• 00880304679108: 110018725
• 00880304679092: 110018724
• 00880304679085: 110018723
• 00880304679078: 110018722
• 00880304679061: 110018721
• 00880304679054: 110018720
• 00880304679047: 110018719
• 00880304679030: 110018718
• 00880304679023: 110018717
• 00880304679016: 110018716
• 00880304678972: 110018712
• 00880304678965: 110018711
• 00880304678958: 110018710
• 00880304678941: 110018709
• 00880304678934: 110018708
• 00880304678927: 110018707
• 00880304678910: 110018706
• 00880304678903: 110018705
• 00880304678897: 110018704
• 00880304678880: 110018703
• 00880304678873: 110018702
• 00880304678866: 110018701