NexGen Standard P-Ref 4-in-1 SSI005799

GUDID 00889024587144

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00889024587144
• NIH Device Record Key: 2b2b40a6-4fe4-4065-a672-4ecc87f277cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NexGen Standard P-Ref 4-in-1
• Version Model Number: SSI005799
• Catalog Number: SSI005799
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• 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: false
• Serial Number: true
• 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

• 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	00889024587144 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031061

FDA Product Code

• MBH: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Sterilization

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

[00889024587144]

Moist Heat or Steam Sterilization

[00889024587144]

Moist Heat or Steam Sterilization

[00889024587144]

Moist Heat or Steam Sterilization

[00889024587144]

Moist Heat or Steam Sterilization

[00889024587144]

Moist Heat or Steam Sterilization

[00889024587144]

Moist Heat or Steam Sterilization

[00889024587144]

Moist Heat or Steam Sterilization

[00889024587144]

Moist Heat or Steam Sterilization

[00889024587144]

Moist Heat or Steam Sterilization

[00889024587144]

Moist Heat or Steam Sterilization

[00889024587144]

Moist Heat or Steam Sterilization

[00889024587144]

Moist Heat or Steam Sterilization

[00889024587144]

Moist Heat or Steam Sterilization

[00889024587144]

Moist Heat or Steam Sterilization

[00889024587144]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-13
• Device Publish Date: 2020-02-05

On-Brand Devices [NexGen Standard P-Ref 4-in-1]

• 00889024587151: SSI005800
• 00889024587144: SSI005799
• 00889024587137: SSI005798
• 00889024587120: SSI005797
• 00889024587113: SSI005796
• 00889024587106: SSI005795