34146

GUDID 07332747013962

Cover Screw NobelActive Internal RP

Nobel Biocare AB

Screw endosteal dental implant, two-piece

• Primary Device ID: 07332747013962
• NIH Device Record Key: 0b005272-85e8-4063-b799-fb349f9578a1
• Commercial Distribution Discontinuation: 2018-03-14
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 34146
• Catalog Number: 34146
• Company DUNS: 353939929
• Company Name: Nobel Biocare AB
• 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: 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)322-5001
• Email: us.customerservice@nobelbiocare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747013962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071370

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-31
• Device Publish Date: 2015-09-17

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