A.L.P.S.® PROXIMAL HUMERUS PLATING SYSTEM3.2MM CALIBRATED DRILL BIT 110017537

GUDID 00887868134968

Biomet Orthopedics, LLC

Fluted surgical drill bit, single-use, non-sterile

• Primary Device ID: 00887868134968
• NIH Device Record Key: ab1b8ad2-ea98-45b7-9df5-882b5ea4d9d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A.L.P.S.® PROXIMAL HUMERUS PLATING SYSTEM3.2MM CALIBRATED DRILL BIT
• Version Model Number: 110017537
• Catalog Number: 110017537
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00887868134968 [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

[00887868134968]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-03-23

On-Brand Devices [A.L.P.S.® PROXIMAL HUMERUS PLATING SYSTEM3.2MM CALIBRATED DRILL BIT]

• 00887868134968: 110017537
• 00887868134845: 110017737