PSN P-REF 4-IN-1 PEG SSI005338

GUDID 00889024581654

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00889024581654
• NIH Device Record Key: d9d1ab74-146e-4a1e-9959-2d8bf08946cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PSN P-REF 4-IN-1 PEG
• Version Model Number: SSI005338
• Catalog Number: SSI005338
• 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	00889024581654 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142787

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

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

[00889024581654]

Moist Heat or Steam Sterilization

[00889024581654]

Moist Heat or Steam Sterilization

[00889024581654]

Moist Heat or Steam Sterilization

[00889024581654]

Moist Heat or Steam Sterilization

[00889024581654]

Moist Heat or Steam Sterilization

[00889024581654]

Moist Heat or Steam Sterilization

[00889024581654]

Moist Heat or Steam Sterilization

[00889024581654]

Moist Heat or Steam Sterilization

[00889024581654]

Moist Heat or Steam Sterilization

[00889024581654]

Moist Heat or Steam Sterilization

[00889024581654]

Moist Heat or Steam Sterilization

[00889024581654]

Moist Heat or Steam Sterilization

[00889024581654]

Moist Heat or Steam Sterilization

[00889024581654]

Moist Heat or Steam Sterilization

[00889024581654]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-19
• Device Publish Date: 2020-02-11

On-Brand Devices [PSN P-REF 4-IN-1 PEG]

• 00889024581685: SSI005341
• 00889024581678: SSI005340
• 00889024581661: SSI005339
• 00889024581654: SSI005338
• 00889024581647: SSI005337
• 00889024581630: SSI005336
• 00889024581623: SSI005335
• 00889024581616: SSI005334
• 00889024581609: SSI005333
• 00889024581593: SSI005332