Zimmer ZFX Component

GUDID 00889024014404

ZIMMER DENTAL INC.

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00889024014404
• NIH Device Record Key: c97685cb-75d3-4498-aa74-93dfb25cb1ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zimmer ZFX Component
• Version Model Number: COPANAZR
• Company DUNS: 103167086
• Company Name: ZIMMER DENTAL INC.
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024014404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093748

FDA Product Code

• EJH: ALLOY, METAL, BASE

Sterilization

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

[00889024014404]

Moist Heat or Steam Sterilization

[00889024014404]

Moist Heat or Steam Sterilization

[00889024014404]

Moist Heat or Steam Sterilization

[00889024014404]

Moist Heat or Steam Sterilization

[00889024014404]

Moist Heat or Steam Sterilization

[00889024014404]

Moist Heat or Steam Sterilization

[00889024014404]

Moist Heat or Steam Sterilization

[00889024014404]

Moist Heat or Steam Sterilization

[00889024014404]

Moist Heat or Steam Sterilization

[00889024014404]

Moist Heat or Steam Sterilization

[00889024014404]

Moist Heat or Steam Sterilization

[00889024014404]

Moist Heat or Steam Sterilization

[00889024014404]

Moist Heat or Steam Sterilization

[00889024014404]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-10-23

On-Brand Devices [Zimmer ZFX Component]

• 00889024344433: ZFX09000628
• 00889024344426: ZFX09000627
• 00889024020696: ZFX09000642
• 00889024020689: ZFX09000641
• 00889024020306: VENEERZR
• 00889024020283: VENEERTI
• 00889024020276: VENEERPMMA
• 00889024020252: VENEERCOCR
• 00889024018723: TELEZR
• 00889024018709: TELETI
• 00889024018693: TELECOCR
• 00889024015623: MHLASP
• 00889024015593: INLAYZR
• 00889024015579: INLAYTI
• 00889024015548: INLAYCOCR
• 00889024014831: FBRIDGEZR
• 00889024014817: FBRIDGETI
• 00889024014787: FBRIDGECOCR
• 00889024014541: CROWNZR
• 00889024014527: CROWNTI
• 00889024014510: CROWNPMMA
• 00889024014497: CROWNEMAX
• 00889024014480: CROWNCOCR
• 00889024014473: COPINGZR
• 00889024014459: COPINGTI
• 00889024014428: COPINGEMAX
• 00889024014411: COPINGCOCR
• 00889024014404: COPANAZR
• 00889024014381: COPANATI
• 00889024014350: COPANAEMAX
• 00889024014343: COPANACOCR
• 00889024015562: INLAYPMMA
• 00889024014800: FBRIDGEPMMA
• 00889024014442: COPINGPMMA
• 00889024014374: COPANAPMMA