ARCOS MODULAR REVISION SYSTEM 31-301612

GUDID 00880304483538

Biomet Orthopedics, LLC

Femoral stem prosthesis trial

• Primary Device ID: 00880304483538
• NIH Device Record Key: 26b9d22d-110d-4b3a-8537-20422915c962
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARCOS MODULAR REVISION SYSTEM
• Version Model Number: 31-301612
• Catalog Number: 31-301612
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304483538 [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

[00880304483538]

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: 2016-10-28

On-Brand Devices [ARCOS MODULAR REVISION SYSTEM]

• 00880304676084: CALCAR BODY TRIAL - BASIC, SIZE A 50MM +0 STANDARD OFFSET
• 00880304676022: 31-311357
• 00880304676015: 31-311356
• 00880304675957: 31-311347
• 00880304675940: 31-311346
• 00880304675889: 31-311337
• 00880304675872: 31-311336
• 00880304675810: 31-311327
• 00880304675803: 31-311326
• 00880304675742: 31-311317
• 00880304675735: 31-311316
• 00880304675674: 31-311307
• 00880304675667: 31-311306
• 00880304675582: CALCAR BODY TRIAL - BASIC, SIZE A 50MM +0 HIGH OFFSET
• 00880304675568: 110018394
• 00880304675551: 110018393
• 00880304675544: 110018392
• 00880304675537: 110018391
• 00880304675520: 110018390
• 00880304675513: 110018389
• 00880304675506: 110018388
• 00880304607781: 31-301804
• 00880304607774: 31-301803
• 00880304607767: 31-301802
• 00880304508279: 31-302024
• 00880304507555: 31-302026
• 00880304506244: 31-301327
• 00880304506220: 31-301357
• 00880304506213: 31-301356
• 00880304506206: 31-302021
• 00880304505018: 31-301623
• 00880304505001: 31-301834
• 00880304504981: 31-301336
• 00880304504974: 31-301316
• 00880304504967: 31-301526
• 00880304504950: 31-301726
• 00880304504936: 31-301337
• 00880304504929: 31-302023
• 00880304504912: 31-301835
• 00880304504899: 31-301621
• 00880304504882: 31-301626
• 00880304504875: 31-301525
• 00880304504868: 31-301521
• 00880304504844: 31-301723
• 00880304504837: 31-301886
• 00880304504820: 31-301836
• 00880304504813: 31-301832
• 00880304504806: 31-301721
• 00880304504790: 31-301887
• 00880304504783: 31-301625