34582

GUDID 07332747024746

Twist Step Drill 4.2/4.6 7-15mm

Nobel Biocare AB

Fluted surgical drill bit, single-use, sterile Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use Fluted surgical drill bit, single-use
Primary Device ID07332747024746
NIH Device Record Keyc803a5a7-83bf-42ce-a2d3-a6670d29b459
Commercial Distribution StatusIn Commercial Distribution
Version Model Number34582
Catalog Number34582
Company DUNS353939929
Company NameNobel Biocare AB
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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

Device Dimensions

Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 Millimeter
Outer Diameter4.6 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747024746 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDRILL, BONE, POWERED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-31
Device Publish Date2016-09-17

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