DLC Step Drill 3.4/2.8mm (6-13mmL) SD3.4CS

GUDID 10841307124764

IMPLANT DIRECT SYBRON MANUFACTURING LLC

Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable Fluted surgical drill bit, reusable
Primary Device ID10841307124764
NIH Device Record Key0a6173a6-290d-44fe-995a-8b25816a3668
Commercial Distribution StatusIn Commercial Distribution
Brand NameDLC Step Drill 3.4/2.8mm (6-13mmL)
Version Model NumberSD3.4CS
Catalog NumberSD3.4CS
Company DUNS868856969
Company NameIMPLANT DIRECT SYBRON MANUFACTURING LLC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com
Phone1-888-649-6425
Emailcustomerservice@implantdirect.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110841307124764 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDrill, Bone, Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10841307124764]

Moist Heat or Steam Sterilization


[10841307124764]

Moist Heat or Steam Sterilization


[10841307124764]

Moist Heat or Steam Sterilization


[10841307124764]

Moist Heat or Steam Sterilization


[10841307124764]

Moist Heat or Steam Sterilization


[10841307124764]

Moist Heat or Steam Sterilization


[10841307124764]

Moist Heat or Steam Sterilization


[10841307124764]

Moist Heat or Steam Sterilization


[10841307124764]

Moist Heat or Steam Sterilization


[10841307124764]

Moist Heat or Steam Sterilization


[10841307124764]

Moist Heat or Steam Sterilization


[10841307124764]

Moist Heat or Steam Sterilization


[10841307124764]

Moist Heat or Steam Sterilization


[10841307124764]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-18
Device Publish Date2020-08-10

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00841307129540 - Long Fixation Screw2024-03-20
00841307129557 - Fixation Screw2024-03-20
00841307129571 - Duo-Grip™ Long Fixation Screw2024-03-20
00841307129588 - Duo-Grip™ Fixation Screw2024-03-20
00841307129595 - Duo-Grip™ Fixation Screw Extra Short2024-03-20

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