ZMR® 00-9978-018-35

GUDID 00889024160316

Zimmer, Inc.

Femoral stem prosthesis trial

• Primary Device ID: 00889024160316
• NIH Device Record Key: bf3aef21-4370-4734-81b9-8575ab47eeac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZMR®
• Version Model Number: 9978-18-35
• Catalog Number: 00-9978-018-35
• 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: 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)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@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	00889024160316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113296

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

[00889024160316]

Moist Heat or Steam Sterilization

[00889024160316]

Moist Heat or Steam Sterilization

[00889024160316]

Moist Heat or Steam Sterilization

[00889024160316]

Moist Heat or Steam Sterilization

[00889024160316]

Moist Heat or Steam Sterilization

[00889024160316]

Moist Heat or Steam Sterilization

[00889024160316]

Moist Heat or Steam Sterilization

[00889024160316]

Moist Heat or Steam Sterilization

[00889024160316]

Moist Heat or Steam Sterilization

[00889024160316]

Moist Heat or Steam Sterilization

[00889024160316]

Moist Heat or Steam Sterilization

[00889024160316]

Moist Heat or Steam Sterilization

[00889024160316]

Moist Heat or Steam Sterilization

[00889024160316]

Moist Heat or Steam Sterilization

[00889024160316]

Moist Heat or Steam Sterilization

[00889024160316]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-06-23
• Device Publish Date: 2016-07-21

On-Brand Devices [ZMR®]

• 00889024158733: 9965-73-02
• 00889024162655: 9998-19-55
• 00889024162648: 9998-19-45
• 00889024162631: 9998-19-35
• 00889024162624: 9998-18-55
• 00889024162617: 9998-18-45
• 00889024162600: 9998-18-35
• 00889024162594: 9998-17-55
• 00889024162587: 9998-17-45
• 00889024162570: 9998-17-35
• 00889024162563: 9998-16-35
• 00889024162556: 9997-19-55
• 00889024162549: 9997-19-45
• 00889024162532: 9997-18-55
• 00889024162525: 9997-18-45
• 00889024162518: 9997-17-55
• 00889024162501: 9997-17-45
• 00889024162488: 00-9996-051-00
• 00889024162471: 00-9996-050-00
• 00889024162464: 9996-23-35
• 00889024162457: 9996-21-35
• 00889024162440: 9996-20-35
• 00889024162433: 9996-19-55
• 00889024162426: 9996-19-45
• 00889024162419: 9996-19-35
• 00889024162402: 9996-18-55
• 00889024162396: 9996-18-45
• 00889024162389: 9996-18-35
• 00889024162372: 9996-17-55
• 00889024162365: 9996-17-45
• 00889024162358: 9996-17-35
• 00889024162341: 9996-16-35
• 00889024162334: 9994-23-55
• 00889024162327: 9994-23-45
• 00889024162310: 9994-21-55
• 00889024162303: 9994-21-45
• 00889024162297: 9994-20-55
• 00889024162280: 9994-20-45
• 00889024162273: 9994-19-55
• 00889024162266: 9994-19-45
• 00889024162259: 9994-18-55
• 00889024162242: 9994-18-45
• 00889024162235: 9994-17-55
• 00889024162228: 9994-17-45
• 00889024162211: 9993-23-55
• 00889024162204: 9993-23-45
• 00889024162198: 9993-23-35
• 00889024162181: 9993-21-55
• 00889024162174: 9993-21-45
• 00889024162167: 9993-21-35