PureSet PUR0500

GUDID 07332747167153

Prosthetic PureSet Tray

Nobel Biocare AB

Instrument tray

• Primary Device ID: 07332747167153
• NIH Device Record Key: 8b9105d6-e43b-4c26-a1e8-ac8490ceb7d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PureSet
• Version Model Number: PUR0500
• Catalog Number: PUR0500
• Company DUNS: 353939929
• Company Name: Nobel Biocare AB
• 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: false
• OTC Over-The-Counter: true

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
• 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
• 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
• 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 Dimensions

• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter
• Length: 122.1 Millimeter
• Height: 45.6 Millimeter
• Width: 115 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight. Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332747167153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191475

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

[07332747167153]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-09-27
• Device Publish Date: 2019-09-19

On-Brand Devices [PureSet]

• 07332747149982: NobelReplace® CC PureSet Tray
• 07332747149975: NobelActive®/NobelParallel™ CC PureSet Tray
• 07332747167184: Nobel Biocare N1™ PureSet Tray
• 07332747167177: Nobel Biocare N1™ PureSet Plate
• 07332747167160: Prosthetic PureSet Plate
• 07332747167153: Prosthetic PureSet Tray