Comprehensive® Shoulder System 11-113564

GUDID 00887868343858

Biomet Orthopedics, LLC

Coated shoulder humeral stem prosthesis

• Primary Device ID: 00887868343858
• NIH Device Record Key: 24c05642-e17b-4e35-a4c6-a01d6ec31baf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive® Shoulder System
• Version Model Number: 11-113564
• Catalog Number: 11-113564
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00887868343858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023063

FDA Product Code

• KWS: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-15

On-Brand Devices [Comprehensive® Shoulder System]

• 00880304826526: 110030060
• 00880304457430: 407391
• 00880304456853: 407320
• 00880304456839: 407319
• 00880304456822: 407318
• 00880304456808: 407393
• 00880304456792: 407305
• 00880304456785: 407304
• 00880304456693: 407316
• 00880304456686: 407317
• 00880304453203: 407309
• 00880304453197: 407312
• 00880304453180: 407313
• 00880304453173: 407311
• 00880304453166: 407307
• 00880304453159: 407314
• 00880304453142: 407310
• 00880304453135: 407306
• 00880304453128: 407308
• 00880304453111: 407315
• 00887868343858: 11-113564
• 00887868343841: 11-113562
• 00887868343834: 11-113560
• 00887868343827: 11-113558
• 00887868343810: 11-113556
• 00887868343803: 11-113554
• 00887868264030: US-115740
• 00887868264023: US-115738
• 00887868264016: US-115736
• 00887868264009: US-115734
• 00887868263996: US-115732
• 00887868263989: US-115730
• 00887868348563: 110017162
• 00887868348556: 110017161
• 00887868462979: 110004319
• 00887868525667: 31-406990
• 00887868525650: 31-406921
• 00887868525643: 31-406920
• 00887868525636: 31-406919
• 00887868525629: 31-406917
• 00887868528644: 593691
• 00887868479830: 31-406999
• 00887868479823: 31-406998
• 00887868479816: 31-406997
• 00887868479809: 31-406996
• 00887868479793: 31-406995
• 00887868479786: 31-406994
• 00887868479779: 31-406993
• 00887868479762: 31-406991
• 00887868479755: 31-406988