OSS(TM) 32-472056

GUDID 00880304007154

Biomet Orthopedics, LLC

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• Primary Device ID: 00880304007154
• NIH Device Record Key: 58630afc-8313-4f88-8d29-21177e080e6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSS(TM)
• Version Model Number: 32-472056
• Catalog Number: 32-472056
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304007154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141331

FDA Product Code

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

Sterilization

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

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

Moist Heat or Steam Sterilization

[00880304007154]

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 [OSS(TM)]

• 00880304505209: 32-472165
• 00880304454743: 32-472187
• 00880304347564: 32-472665
• 00880304347328: 32-472110
• 00880304347311: 32-472109
• 00880304347304: 32-472108
• 00880304347274: 32-472105
• 00880304347267: 32-472104
• 00880304347250: 32-472103
• 00880304347243: 32-472102
• 00880304347236: 32-472101
• 00880304347229: 32-472100
• 00880304347212: 32-472099
• 00880304347205: 32-472098
• 00880304347199: 32-472097
• 00880304347182: 32-472096
• 00880304347175: 32-472095
• 00880304347168: 32-472094
• 00880304347151: 32-472093
• 00880304347144: 32-472092
• 00880304347137: 32-472091
• 00880304347120: 32-472090
• 00880304347113: 32-472089
• 00880304347106: 32-472088
• 00880304347090: 32-472087
• 00880304347083: 32-472086
• 00880304347076: 32-472085
• 00880304347052: 32-472083
• 00880304347045: 32-472082
• 00880304347038: 32-472081
• 00880304347021: 32-472080
• 00880304347014: 32-472079
• 00880304347007: 32-472078
• 00880304346994: 32-472077
• 00880304346987: 32-472076
• 00880304346970: 32-472075
• 00880304346963: 32-472074
• 00880304346956: 32-472073
• 00880304346949: 32-472072
• 00880304346932: 32-472071
• 00880304346925: 32-472070
• 00880304346918: 32-472069
• 00880304346901: 32-472068
• 00880304346895: 32-472067
• 00880304346888: 32-472066
• 00880304346871: 32-472065
• 00880304346864: 32-472064
• 00880304346857: 32-472063
• 00880304346840: 32-472062
• 00880304346833: 32-472061