OSS™ 110008543

GUDID 00887868463303

Biomet Orthopedics, LLC

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00887868463303
• NIH Device Record Key: 57dad9ed-3584-46bb-acaa-fefa3bc0e422
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSS™
• Version Model Number: 110008543
• Catalog Number: 110008543
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868463303 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131393

FDA Product Code

• KRO: PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[00887868463303]

Moist Heat or Steam Sterilization

[00887868463303]

Moist Heat or Steam Sterilization

[00887868463303]

Moist Heat or Steam Sterilization

[00887868463303]

Moist Heat or Steam Sterilization

[00887868463303]

Moist Heat or Steam Sterilization

[00887868463303]

Moist Heat or Steam Sterilization

[00887868463303]

Moist Heat or Steam Sterilization

[00887868463303]

Moist Heat or Steam Sterilization

[00887868463303]

Moist Heat or Steam Sterilization

[00887868463303]

Moist Heat or Steam Sterilization

[00887868463303]

Moist Heat or Steam Sterilization

[00887868463303]

Moist Heat or Steam Sterilization

[00887868463303]

Moist Heat or Steam Sterilization

[00887868463303]

Moist Heat or Steam Sterilization

[00887868463303]

Moist Heat or Steam Sterilization

[00887868463303]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-31
• Device Publish Date: 2021-03-23

On-Brand Devices [OSS™]

• 00887868519864: 110018656
• 00887868519857: 110018657
• 00887868468049: 110018713
• 00887868468032: 110018712
• 00887868468025: 110018711
• 00887868468018: 110018710
• 00887868468001: 110018709
• 00887868467998: 110018708
• 00887868467981: 110018707
• 00887868467974: 110018706
• 00887868467967: 110018705
• 00887868467950: 110018704
• 00887868467943: 110018703
• 00887868467936: 110018702
• 00887868467929: 110018701
• 00887868467912: 110018700
• 00887868467905: 110018699
• 00887868467899: 110018698
• 00887868467882: 110018697
• 00887868467875: 110018696
• 00887868467868: 110018695
• 00887868467851: 110018694
• 00887868467844: 110018693
• 00887868467837: 110018692
• 00887868467820: 110018691
• 00887868467813: 110018690
• 00887868467806: 110018689
• 00887868467790: 110018688
• 00887868467783: 110018687
• 00887868467776: 110018686
• 00887868467769: 110018685
• 00887868467752: 110018684
• 00887868467745: 110018683
• 00887868467738: 110018682
• 00887868467721: 110018681
• 00887868467714: 110018680
• 00887868467707: 110018679
• 00887868467691: 110018678
• 00887868467684: 110018677
• 00887868467677: 110018676
• 00887868467660: 110018675
• 00887868467653: 110018674
• 00887868467646: 110018673
• 00887868467639: 110018672
• 00887868467622: 110018671
• 00887868467615: 110018670
• 00887868467608: 110018669
• 00887868467592: 110018667
• 00887868467585: 110018665
• 00887868467578: 110018661