OSS STRAIGHT STEM TRIAL 110018690

GUDID 00880304678750

Biomet Orthopedics, LLC

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• Primary Device ID: 00880304678750
• NIH Device Record Key: e30006a0-88e3-462d-aef2-e86a70b60c42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSS STRAIGHT STEM TRIAL
• Version Model Number: 110018690
• Catalog Number: 110018690
• 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	00880304678750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141331

FDA Product Code

• LPH: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Sterilization

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

[00880304678750]

Moist Heat or Steam Sterilization

[00880304678750]

Moist Heat or Steam Sterilization

[00880304678750]

Moist Heat or Steam Sterilization

[00880304678750]

Moist Heat or Steam Sterilization

[00880304678750]

Moist Heat or Steam Sterilization

[00880304678750]

Moist Heat or Steam Sterilization

[00880304678750]

Moist Heat or Steam Sterilization

[00880304678750]

Moist Heat or Steam Sterilization

[00880304678750]

Moist Heat or Steam Sterilization

[00880304678750]

Moist Heat or Steam Sterilization

[00880304678750]

Moist Heat or Steam Sterilization

[00880304678750]

Moist Heat or Steam Sterilization

[00880304678750]

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 STRAIGHT STEM TRIAL]

• 00880304679009: 110018715
• 00880304678996: 110018714
• 00880304678989: 110018713
• 00880304678859: 110018700
• 00880304678842: 110018699
• 00880304678835: 110018698
• 00880304678828: 110018697
• 00880304678811: 110018696
• 00880304678804: 110018695
• 00880304678798: 110018694
• 00880304678781: 110018693
• 00880304678774: 110018692
• 00880304678767: 110018691
• 00880304678750: 110018690
• 00880304678743: 110018689
• 00880304678736: 110018688
• 00880304678729: 110018687
• 00880304678712: 110018686
• 00880304678705: 110018685
• 00880304678699: 110018684
• 00880304678682: 110018683
• 00880304678675: 110018682