47-2255-008-00

GUDID 00889024581838

Zimmer, Inc.

Orthopaedic prosthesis implantation instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 00889024581838
• NIH Device Record Key: e7162554-ce91-4364-84b8-511540ac3ab9
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 47-2255-008-00
• Catalog Number: 47-2255-008-00
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Device Dimensions

• Length: 70 Centimeter
• Device Size Text, specify: 0
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Length: 70 Centimeter
• Device Size Text, specify: 0
• Length: 70 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024581838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191238

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-23
• Device Publish Date: 2019-07-15

Devices Manufactured by Zimmer, Inc.

• 00889024673434 - RIGID SUPRA ENTRY SLEEVE 13MM: 2024-06-14
• 00889024673441 - RIGID SUPRA ENTRY SLEEVE 15MM: 2024-06-14
• 00889024673458 - RIGID SUPRA ENTRY SLEEVE TIBIAL PIN FIX 13MM: 2024-06-14
• 00889024673465 - RIGID SUPRA ENTRY SLEEVE TIBIAL PIN FIX 15MM: 2024-06-14
• 00889024673779 - ALLIANCE UNIV AUG SIZER SZ 2: 2024-06-14
• 00889024673786 - ALLIANCE UNIV AUG SIZER SZ 3: 2024-06-14
• 00889024673793 - ALLIANCE UNIV AUG SIZER SZ 4: 2024-06-14
• 00889024673809 - ALLIANCE UNIV AUG SIZER SZ 5: 2024-06-14