Biomet Proximal Humeral Plating System SSI004254

GUDID 00887868240317

Biomet Orthopedics, LLC

Surgical drill guide, single-use

• Primary Device ID: 00887868240317
• NIH Device Record Key: ec6c3718-f1ac-450c-918d-a68b989121da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biomet Proximal Humeral Plating System
• Version Model Number: SSI004254
• Catalog Number: SSI004254
• 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) 343-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868240317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143697

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[00887868240317]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2018-03-26

On-Brand Devices [Biomet Proximal Humeral Plating System]

• 00887868240324: SSI004255
• 00887868240317: SSI004254