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

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

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


Device Entry Metadata

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

Devices Manufactured by Nobel Biocare AB

07332747216882 - Nobel Biocare®2025-03-06 Healing Abutment Conical Connection 3.0 Ø3.3x3mm
07332747216899 - Nobel Biocare®2025-03-06 Healing Abutment Conical Connection 3.0 Ø3.3x4mm
07332747216905 - Nobel Biocare®2025-03-06 Healing Abutment Conical Connection 3.0 Ø3.3x5mm
07332747216912 - Nobel Biocare®2025-03-06 Healing Abutment Conical Connection 3.0 Ø3.3x7mm
07332747216929 - Nobel Biocare®2025-03-06 Healing Abutment Conical Connection 3.0 Ø4x3mm
07332747216936 - Nobel Biocare®2025-03-06 Healing Abutment Conical Connection 3.0 Ø4x4mm
07332747216943 - Nobel Biocare®2025-03-06 Healing Abutment Conical Connection 3.0 Ø4x5mm
07332747216950 - Nobel Biocare®2025-03-06 Healing Abutment Conical Connection 3.0 Ø4x7mm

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.