Integral® Omniloc™

GUDID 00889024011236

ZIMMER DENTAL INC.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 00889024011236
• NIH Device Record Key: 980504e4-82b8-4c3b-9a80-52f8ef5dab6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integral® Omniloc™
• Version Model Number: 0724
• Company DUNS: 103167086
• Company Name: ZIMMER DENTAL INC.
• Device Count: 2
• DM Exempt: true
• 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: 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)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com
• Phone: +1(800)854-7019
• Email: zimmer.consumerrelations@zimmer.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• 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	00889024011236 [Primary]
GS1	00889024209190 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900549

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

[00889024011236]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2017-09-01

On-Brand Devices [Integral® Omniloc™]

• 00889024011328: 0777
• 00889024011311: 0776
• 00889024011304: 0775
• 00889024011243: 0746
• 00889024010871: 0388
• 00889024010864: 0387
• 00889024010857: 0385
• 00889024011410: 0947
• 00889024011342: 0812
• 00889024011236: 0724
• 00889024011205: 0714