PureSet PUR0500

GUDID 07332747167153

Prosthetic PureSet Tray

Nobel Biocare AB

Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray 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 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 Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable
Primary Device ID07332747167153
NIH Device Record Key8b9105d6-e43b-4c26-a1e8-ac8490ceb7d6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePureSet
Version Model NumberPUR0500
Catalog NumberPUR0500
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 Datefalse
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
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
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

Device Dimensions

Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter
Length122.1 Millimeter
Height45.6 Millimeter
Width115 Millimeter

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747167153 [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

[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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-27
Device Publish Date2019-09-19

On-Brand Devices [PureSet]

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