RECONSTRUCTIVE WEDGE 110004029

GUDID 00887868106804

Biomet Orthopedics, LLC

Orthopaedic implant/trial-implant holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable Surgical implant/trial-implant/sizer holder, reusable

• Primary Device ID: 00887868106804
• NIH Device Record Key: 44cbfce5-9651-4336-a6f6-9e5021aa398c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RECONSTRUCTIVE WEDGE
• Version Model Number: 110004029
• Catalog Number: 110004029
• 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: true
• 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
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• 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 Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868106804 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122770

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00887868106804]

Moist Heat or Steam Sterilization

[00887868106804]

Moist Heat or Steam Sterilization

[00887868106804]

Moist Heat or Steam Sterilization

[00887868106804]

Moist Heat or Steam Sterilization

[00887868106804]

Moist Heat or Steam Sterilization

[00887868106804]

Moist Heat or Steam Sterilization

[00887868106804]

Moist Heat or Steam Sterilization

[00887868106804]

Moist Heat or Steam Sterilization

[00887868106804]

Moist Heat or Steam Sterilization

[00887868106804]

Moist Heat or Steam Sterilization

[00887868106804]

Moist Heat or Steam Sterilization

[00887868106804]

Moist Heat or Steam Sterilization

[00887868106804]

Moist Heat or Steam Sterilization

[00887868106804]

Moist Heat or Steam Sterilization

[00887868106804]

Moist Heat or Steam Sterilization

[00887868106804]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-28

On-Brand Devices [RECONSTRUCTIVE WEDGE]

• 00880304928282: 110004037
• 00887868106804: 110004029
• 00887868106798: 110004025
• 00887868106781: 110004021
• 00887868106811: 110004033