PureSet™ PUR1000

GUDID 07332747198188

NobelZygoma™ PureSet Tray

Nobel Biocare AB

Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable
Primary Device ID07332747198188
NIH Device Record Key1ba8ba18-43dd-474e-a35f-012dbe7dd9c4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureSet™
Version Model NumberPUR1000
Catalog NumberPUR1000
Company DUNS353939929
Company NameNobel Biocare AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747198188 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization wrap containers, trays, cassettes & other accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


[07332747198188]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-10
Device Publish Date2023-08-02

On-Brand Devices [PureSet™]

07332747198195NobelZygoma™ PureSet Plate
07332747198188NobelZygoma™ PureSet Tray

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