Comprehensive Reverse Shoulder Mini Baseplate SSI004621

GUDID 00887868259067

Biomet Orthopedics, LLC

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00887868259067
• NIH Device Record Key: bff9acc1-3344-47b0-a09f-68f60b365230
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comprehensive Reverse Shoulder Mini Baseplate
• Version Model Number: SSI004621
• Catalog Number: SSI004621
• 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
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Width: 3.5 Millimeter
• Width: 3.5 Millimeter
• Width: 3.5 Millimeter
• Width: 3.5 Millimeter
• Width: 3.5 Millimeter
• Width: 3.5 Millimeter
• Width: 3.5 Millimeter
• Width: 3.5 Millimeter
• Width: 3.5 Millimeter
• Width: 3.5 Millimeter
• Width: 3.5 Millimeter
• Width: 3.5 Millimeter
• Width: 3.5 Millimeter
• Width: 3.5 Millimeter
• Width: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868259067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120121

FDA Product Code

• KWS: Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Sterilization

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

[00887868259067]

Moist Heat or Steam Sterilization

[00887868259067]

Moist Heat or Steam Sterilization

[00887868259067]

Moist Heat or Steam Sterilization

[00887868259067]

Moist Heat or Steam Sterilization

[00887868259067]

Moist Heat or Steam Sterilization

[00887868259067]

Moist Heat or Steam Sterilization

[00887868259067]

Moist Heat or Steam Sterilization

[00887868259067]

Moist Heat or Steam Sterilization

[00887868259067]

Moist Heat or Steam Sterilization

[00887868259067]

Moist Heat or Steam Sterilization

[00887868259067]

Moist Heat or Steam Sterilization

[00887868259067]

Moist Heat or Steam Sterilization

[00887868259067]

Moist Heat or Steam Sterilization

[00887868259067]

Moist Heat or Steam Sterilization

[00887868259067]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-27
• Device Publish Date: 2018-07-26

On-Brand Devices [Comprehensive Reverse Shoulder Mini Baseplate]

• 00887868256974: SSI000013
• 00887868259067: SSI004621
• 00887868243912: SSI002750
• 00887868243905: SSI002749
• 00887868243899: SSI002748
• 00887868243882: SSI002747