Mergence™-S

GUDID 00889024318373

ZIMMER TRABECULAR METAL TECHNOLOGY INC.

Orthopaedic prosthesis implantation instrument, reusable

• Primary Device ID: 00889024318373
• NIH Device Record Key: fd2eba6d-fd77-40f5-a62e-627b7de6074f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mergence™-S
• Version Model Number: 96-108-67111
• Company DUNS: 793120965
• Company Name: ZIMMER TRABECULAR METAL TECHNOLOGY 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@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

Device Dimensions

• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024318373 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133784

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[00889024318373]

Moist Heat or Steam Sterilization

[00889024318373]

Moist Heat or Steam Sterilization

[00889024318373]

Moist Heat or Steam Sterilization

[00889024318373]

Moist Heat or Steam Sterilization

[00889024318373]

Moist Heat or Steam Sterilization

[00889024318373]

Moist Heat or Steam Sterilization

[00889024318373]

Moist Heat or Steam Sterilization

[00889024318373]

Moist Heat or Steam Sterilization

[00889024318373]

Moist Heat or Steam Sterilization

[00889024318373]

Moist Heat or Steam Sterilization

[00889024318373]

Moist Heat or Steam Sterilization

[00889024318373]

Moist Heat or Steam Sterilization

[00889024318373]

Moist Heat or Steam Sterilization

[00889024318373]

Moist Heat or Steam Sterilization

[00889024318373]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-20

On-Brand Devices [Mergence™-S]

• 00889024320451: 96-299-55011
• 00889024320444: 96-299-55001
• 00889024320437: 96-299-54011
• 00889024320420: 96-299-54001
• 00889024320413: 96-299-53011
• 00889024320406: 96-299-53001
• 00889024320390: 96-299-52021
• 00889024320383: 96-299-52011
• 00889024320376: 96-299-52001
• 00889024320369: 96-299-51011
• 00889024320352: 96-299-51001
• 00889024320345: 96-299-50031
• 00889024320338: 96-299-50021
• 00889024320321: 96-299-50011
• 00889024320314: 96-299-50001
• 00889024318380: 96-108-67121
• 00889024318373: 96-108-67111
• 00889024318366: 96-108-67101
• 00889024318359: 96-108-67091
• 00889024318342: 96-108-67081
• 00889024318335: 96-108-67071
• 00889024318328: 96-108-67061
• 00889024318311: 96-108-67051
• 00889024318304: 96-108-67041
• 00889024318298: 96-108-60121
• 00889024318281: 96-108-60111
• 00889024318274: 96-108-60101
• 00889024318267: 96-108-60091
• 00889024318250: 96-108-60081
• 00889024318243: 96-108-60071
• 00889024318236: 96-108-60061
• 00889024318229: 96-108-60051
• 00889024318212: 96-108-60041
• 00889024318205: 96-108-57121
• 00889024318199: 96-108-57111
• 00889024318182: 96-108-57101
• 00889024318175: 96-108-57091
• 00889024318168: 96-108-57081
• 00889024318151: 96-108-57071
• 00889024318144: 96-108-57061
• 00889024318137: 96-108-57051
• 00889024318120: 96-108-57041
• 00889024318113: 96-108-50121
• 00889024318106: 96-108-50111
• 00889024318090: 96-108-50101
• 00889024318083: 96-108-50091
• 00889024318076: 96-108-50081
• 00889024318069: 96-108-50071
• 00889024318052: 96-108-50061
• 00889024318045: 96-108-50051