ARCOS 31-311305

GUDID 00880304675650

Biomet Orthopedics, LLC

Femoral stem prosthesis trial

• Primary Device ID: 00880304675650
• NIH Device Record Key: 159f8882-7f6d-449d-9b08-5a7c9a61b1a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARCOS
• Version Model Number: 31-311305
• Catalog Number: 31-311305
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304675650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090757

FDA Product Code

• MAY: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish

Sterilization

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

[00880304675650]

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 [ARCOS]

• 00880304676008: 31-311355
• 00880304675995: 31-311354
• 00880304675988: 31-311353
• 00880304675971: 31-311352
• 00880304675964: 31-311351
• 00880304675933: 31-311345
• 00880304675926: 31-311344
• 00880304675919: 31-311343
• 00880304675902: 31-311342
• 00880304675896: 31-311341
• 00880304675865: 31-311335
• 00880304675858: 31-311334
• 00880304675841: 31-311333
• 00880304675834: 31-311332
• 00880304675827: 31-311331
• 00880304675797: 31-311325
• 00880304675780: 31-311324
• 00880304675773: 31-311323
• 00880304675766: 31-311322
• 00880304675759: 31-311321
• 00880304675728: 31-311315
• 00880304675711: 31-311314
• 00880304675704: 31-311313
• 00880304675698: 31-311312
• 00880304675681: 31-311311
• 00880304675650: 31-311305
• 00880304675643: 31-311304
• 00880304675636: 31-311303
• 00880304675629: 31-311302
• 00880304675612: 31-311301
• 00880304675605: 31-311310
• 00880304675599: 31-311300
• 00880304675575: 31-311000
• 00880304506237: 31-301347
• 00880304505049: 31-301346
• 00880304505032: 31-301326
• 00880304505025: 31-301307
• 00880304504998: 31-301306
• 00880304504943: 31-301317
• 00880304504905: 31-301106
• 00880304497672: 31-301837
• 00880304497511: 31-301366
• 00880304497504: 31-301367
• 00880304497474: 31-301842
• 00880304497467: 31-301841
• 00880304497450: 31-301840
• 00880304497443: 31-301839
• 00880304497306: 31-300923
• 00880304497290: 31-300823
• 00880304497276: 31-300925