ZCA®

GUDID 00889024144347

Zimmer, Inc.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 00889024144347
• NIH Device Record Key: 8381f9b7-0936-4314-aec4-96f687d581b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZCA®
• Version Model Number: 8005-210
• Company DUNS: 056038268
• Company Name: Zimmer, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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@zimmer.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
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com
• Phone: +1(800)348-2759
• Email: zimmer.consumerrelations@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024144347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191449

FDA Product Code

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

Sterilization

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

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

[00889024144347]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-23
• Device Publish Date: 2017-02-09

On-Brand Devices [ZCA®]

• 00889024144415: 8005-260-32
• 00889024144408: 8005-260-28
• 00889024144392: 8005-260-26
• 00889024144385: 8005-260-22
• 00889024144361: 8005-250
• 00889024144347: 8005-210
• 00889024144514: 8005-300-61
• 00889024144507: 8005-300-59
• 00889024144491: 8005-300-57
• 00889024144484: 8005-300-55
• 00889024144477: 8005-300-53
• 00889024144460: 8005-300-51
• 00889024144453: 8005-300-49
• 00889024144446: 8005-300-47
• 00889024144439: 8005-300-45
• 00889024144422: 8005-300-43
• 00889024144378: 8005-260
• 00889024144354: 8005-230
• 00889024144330: 8005-96
• 00889024144323: 8005-95
• 00889024144316: 8005-90
• 00889024144163: 8000-216
• 00889024144156: 8000-215
• 00889024144149: 8000-214
• 00889024363502: 8005-958-32
• 00889024363496: 8005-956-32
• 00889024363489: 8005-954-32
• 00889024363472: 8005-952-32
• 00889024363465: 8005-950-32
• 00889024363458: 8005-948-32
• 00889024363441: 8005-946-32
• 00889024362895: 8005-658-32
• 00889024362888: 8005-658-28
• 00889024362871: 8005-658-26
• 00889024362864: 8005-658-22
• 00889024362857: 8005-656-32
• 00889024362840: 8005-656-28
• 00889024362833: 8005-656-26
• 00889024362826: 8005-656-22
• 00889024362819: 8005-654-32
• 00889024362802: 8005-654-28
• 00889024362796: 8005-654-26
• 00889024362789: 8005-654-22
• 00889024362772: 8005-652-32
• 00889024362765: 8005-652-28
• 00889024362758: 8005-652-26
• 00889024362741: 8005-652-22
• 00889024362734: 8005-650-32
• 00889024362727: 8005-650-28
• 00889024362710: 8005-650-26