COMPREHENSIVE 110004203

GUDID 00880304538993

Biomet Orthopedics, LLC

Surgical drill guide, reusable

• Primary Device ID: 00880304538993
• NIH Device Record Key: 62faa148-33ea-4c33-8402-5d277c467d10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPREHENSIVE
• Version Model Number: 110004203
• Catalog Number: 110004203
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304538993 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060694

FDA Product Code

• KWT: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Sterilization

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

[00880304538993]

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: 2016-09-22

On-Brand Devices [COMPREHENSIVE]

• 00880304538993: 110004203
• 00880304537798: 110003481
• 00880304532366: 405807
• 00880304532359: 405909
• 00880304532342: 405803
• 00880304532304: 405907
• 00880304532298: 405809
• 00880304478893: 595501
• 00880304478886: 595503
• 00880304478879: 595502
• 00880304470231: 405958
• 00880304469693: 405886
• 00889024563599: SSI004940
• 00889024573772: SSI005068
• 00889024573765: SSI005067
• 00889024573758: SSI005066
• 00889024573741: SSI005065
• 00889024572898: SSI004998
• 00889024572881: SSI004997
• 00889024572874: SSI004993
• 00889024572867: SSI004992
• 00889024573802: SSI005127
• 00889024573796: SSI005070
• 00889024573789: SSI005069
• 00887868263781: SSI004080
• 00889024569126: SSI004999
• 00889024569119: SSI004707
• 00889024569102: SSI004706
• 00889024569096: SSI004705
• 00880304478862: 595509