NobelActive® 36852

GUDID 07332747039788

NobelActive™ RP 4.3×18mm

Nobel Biocare AB

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• Primary Device ID: 07332747039788
• NIH Device Record Key: d6c07673-4cd3-4713-b955-d99eac170231
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NobelActive®
• Version Model Number: 36852
• Catalog Number: 36852
• 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
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com
• Phone: +1(800)322-5001
• Email: us.customerservice@nobelbiocare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747039788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083205

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

On-Brand Devices [NobelActive®]

• 07332747096279: Guided Dense Bone Screw Tap NobelActive® WP 5.5 10-15 mm
• 07332747096262: Guided Dense Bone Screw Tap NobelActive® WP 5.5 7-8.5 mm
• 07332747096255: Guided Dense Bone Screw Tap NobelActive® RP 5.0 8.5-18 mm
• 07332747096248: Guided Dense Bone Screw Tap NobelActive® RP 4.3 8.5-18 mm
• 07332747096231: Guided Dense Bone Screw Tap NobelActive® NP 8.5-18 mm
• 07332747091144: NobelActive® Guided Surgery Kit
• 07332747091090: Guided Screw Tap NobelActive® WP 5.5 10-15mm
• 07332747091083: Guided Screw Tap NobelActive® WP 5.5 7-8.5mm
• 07332747088397: NobelActive WP 5.5x7mm
• 07332747088380: NobelActive® WP 5.5x8.5mm
• 07332747088373: NobelActive® WP 5.5x10mm
• 07332747088366: NobelActive® WP 5.5x11.5mm
• 07332747088359: NobelActive® WP 5.5x13mm
• 07332747088342: NobelActive® WP 5.5x15mm
• 07332747087741: Screw Tap NobelActive® WP 5.5 7-10mm
• 07332747087734: Screw Tap NobelActive® WP 5.5 11.5-15mm
• 07332747039849: NobelActive™ NP 3.5×18 mm
• 07332747039832: NobelActive™ NP 3.5×8.5mm
• 07332747039825: NobelActive™ NP 3.5x10mm
• 07332747039818: NobelActive™ NP 3.5x11.5mm
• 07332747039801: NobelActive™ NP 3.5x13mm
• 07332747039795: NobelActive™ NP 3.5x15mm
• 07332747039788: NobelActive™ RP 4.3×18mm
• 07332747039771: NobelActive™ RP 4.3×8.5mm
• 07332747039764: NobelActive™ RP 4.3x10mm
• 07332747039757: NobelActive™ RP 4.3x11.5mm
• 07332747039740: NobelActive™ RP 4.3x13mm
• 07332747039733: NobelActive™ RP 4.3x15mm
• 07332747039726: NobelActive™ RP 5.0×18mm
• 07332747039719: NobelActive™ RP 5.0×8.5mm
• 07332747039702: NobelActive™ RP 5.0x10mm
• 07332747039399: NobelActive™ RP 5.0x11.5mm
• 07332747039382: NobelActive™ RP 5.0x13mm
• 07332747039375: NobelActive™ RP 5.0x15mm
• 07332747037739: NobelActive 3.0 3.0x10mm
• 07332747037722: NobelActive 3.0 3.0x11.5mm
• 07332747037715: NobelActive 3.0 3.0x13mm
• 07332747037708: NobelActive 3.0 3.0x15mm
• 07332747036022: Screw Tap NobelActive 3.0
• 07332747028478: Screw Tap NobelActive NP 3.5
• 07332747028461: Screw Tap NobelActive RP 4.3
• 07332747028454: Screw Tap NobelActive RP 5.0
• 07332747015591: Guided Screw Tap NobelActive® RP 5.0x8.5-10mm
• 07332747015584: Guided Screw Tap NobelActive® RP 4.3x8.5-10mm
• 07332747015577: Guided Screw Tap NobelActive® NP 8.5-10mm
• 07332747013139: Bone Mill w Guide NobelActive Int RP
• 07332747013122: Bone Mill w Guide NobelActive Int NP
• 07332747169034: NobelActive® Guided PureSet Tray
• 07332747161175: NobelActive® WP 5.5x15mm
• 07332747161168: NobelActive® WP 5.5x13mm