PUR0900

GUDID 07332747178913

NobelSpeedy/Brånemark Syst/Replace Sel TC PureSet™ Tray

Nobel Biocare AB

Instrument tray, reusable
Primary Device ID07332747178913
NIH Device Record Keyc0e2a491-6612-484d-9313-12da2feab7cd
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberPUR0900
Catalog NumberPUR0900
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
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

Length276.1 Millimeter
Width176 Millimeter
Height47 Millimeter
Length276.1 Millimeter
Width176 Millimeter
Height47 Millimeter
Length276.1 Millimeter
Width176 Millimeter
Height47 Millimeter
Length276.1 Millimeter
Width176 Millimeter
Height47 Millimeter
Length276.1 Millimeter
Width176 Millimeter
Height47 Millimeter
Length276.1 Millimeter
Width176 Millimeter
Height47 Millimeter
Length276.1 Millimeter
Width176 Millimeter
Height47 Millimeter
Length276.1 Millimeter
Width176 Millimeter
Height47 Millimeter
Length276.1 Millimeter
Width176 Millimeter
Height47 Millimeter
Length276.1 Millimeter
Width176 Millimeter
Height47 Millimeter
Length276.1 Millimeter
Width176 Millimeter
Height47 Millimeter
Length276.1 Millimeter
Width176 Millimeter
Height47 Millimeter
Length276.1 Millimeter
Width176 Millimeter
Height47 Millimeter
Length276.1 Millimeter
Width176 Millimeter
Height47 Millimeter
Length276.1 Millimeter
Width176 Millimeter
Height47 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.
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
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
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
GS107332747178913 [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

[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


[07332747178913]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-02
Device Publish Date2022-01-25

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07332747220469 - Unigrip™ Plus2025-12-29 Screwdriver Manual Unigrip Plus 36 mm
07332747220476 - Unigrip™ Plus2025-12-29 Screwdriver Machine Unigrip Plus 20 mm
07332747220483 - Unigrip™ Plus2025-12-29 Screwdriver Machine Unigrip Plus 25 mm
07332747220490 - Unigrip™ Plus2025-12-29 Screwdriver Machine Unigrip Plus 30 mm
07332747220506 - Unigrip™ Plus2025-12-29 Screwdriver Machine Unigrip Plus 35 mm
07332747221855 - DTX Studio™ Assist2025-12-09 DTX Studio Assist 1.1 for Windows 64-bit

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