SCREW, CORTICAL 815036026

GUDID 00887868040115

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00887868040115
• NIH Device Record Key: e64fd568-a67b-4aee-9452-8fcc4a486e27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCREW, CORTICAL
• Version Model Number: 8150-36-026
• Catalog Number: 815036026
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868040115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905048

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00887868040115]

Moist Heat or Steam Sterilization

[00887868040115]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-24

On-Brand Devices [SCREW, CORTICAL]

• 00887868040375: 8150-36-120
• 00887868040368: 8150-36-115
• 00887868040351: 8150-36-110
• 00887868040344: 8150-36-105
• 00887868040337: 8150-36-100
• 00887868040320: 8150-36-095
• 00887868040313: 8150-36-090
• 00887868040306: 8150-36-085
• 00887868040290: 8150-36-080
• 00887868040283: 8150-36-075
• 00887868040276: 8150-36-070
• 00887868040269: 8150-36-065
• 00887868040252: 8150-36-060
• 00887868040245: 8150-36-055
• 00887868040238: 8150-36-050
• 00887868040221: 8150-36-048
• 00887868040214: 8150-36-046
• 00887868040207: 8150-36-044
• 00887868040191: 8150-36-042
• 00887868040184: 8150-36-040
• 00887868040177: 8150-36-038
• 00887868040160: 8150-36-036
• 00887868040153: 8150-36-034
• 00887868040146: 8150-36-032
• 00887868040139: 8150-36-030
• 00887868040122: 8150-36-028
• 00887868040115: 8150-36-026
• 00887868040108: 8150-36-024
• 00887868040092: 8150-36-022
• 00887868040085: 8150-36-020
• 00887868040078: 8150-36-018
• 00887868040061: 8150-36-016
• 00887868040054: 8150-36-014
• 00887868040047: 8150-36-012
• 00887868040030: 8150-36-010