BIO-MODULAR 406534

GUDID 00880304365308

Biomet Orthopedics, LLC

Humeral head prosthesis trial, reusable

• Primary Device ID: 00880304365308
• NIH Device Record Key: 5a13fa0d-a91b-4c7c-b270-59c631c47f9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIO-MODULAR
• Version Model Number: 406534
• Catalog Number: 406534
• 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	00880304365308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030710

FDA Product Code

• MBF: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Sterilization

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

[00880304365308]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-30
• Device Publish Date: 2017-03-20

On-Brand Devices [BIO-MODULAR]

• 00880304366718: 406802
• 00880304366695: 406769
• 00880304366688: 406767
• 00880304366626: 406760
• 00880304366411: 406729
• 00880304366404: 406728
• 00880304366398: 406727
• 00880304366381: 406726
• 00880304366374: 406725
• 00880304366367: 406724
• 00880304366350: 406723
• 00880304366343: 406722
• 00880304366336: 406721
• 00880304366060: 406631
• 00880304365810: 406597
• 00880304365735: 406589
• 00880304365704: 406586
• 00880304365681: 406584
• 00880304365377: 406540
• 00880304365360: 406539
• 00880304365353: 406538
• 00880304365346: 406537
• 00880304365308: 406534
• 00880304365292: 406532
• 00880304365285: 406531
• 00880304365186: 406514
• 00880304006799: 406533
• 00880304003637: 406599
• 00880304002319: 406530
• 00880304475649: 31-406630
• 00880304397309: 595170
• 00880304397279: 595166