DeGen Navigated Instrumentation 15-10P

GUDID 00842048138839

NAVIGATED MIS CANNULATED SCREW DRIVER

DEGEN MEDICAL, INC.

Surgical screwdriver, reusable
Primary Device ID00842048138839
NIH Device Record Key59da4c43-79fe-4f9f-84ea-771572137fc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDeGen Navigated Instrumentation
Version Model Number15-10P
Catalog Number15-10P
Company DUNS078812602
Company NameDEGEN MEDICAL, INC.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com
Phone+1(877)240-7838
Emailcustomerservice@degenmedical.com

Device Dimensions

Length238.55 Millimeter
Length238.55 Millimeter
Length238.55 Millimeter
Length238.55 Millimeter
Length238.55 Millimeter
Length238.55 Millimeter
Length238.55 Millimeter
Length238.55 Millimeter
Length238.55 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100842048138839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842048138839]

Moist Heat or Steam Sterilization


[00842048138839]

Moist Heat or Steam Sterilization


[00842048138839]

Moist Heat or Steam Sterilization


[00842048138839]

Moist Heat or Steam Sterilization


[00842048138839]

Moist Heat or Steam Sterilization


[00842048138839]

Moist Heat or Steam Sterilization


[00842048138839]

Moist Heat or Steam Sterilization


[00842048138839]

Moist Heat or Steam Sterilization


[00842048138839]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-30
Device Publish Date2021-08-20

On-Brand Devices [DeGen Navigated Instrumentation]

00842048138860NAVIGATED MIS SOLID SCREW DRIVER
00842048138853NAVIGATED OPEN CANNULATED SCREW DRIVER
00842048138846NAVIGATED MIS SOLID SCREW DRIVER
00842048138839NAVIGATED MIS CANNULATED SCREW DRIVER
00842048138822MIS ADAPTER DRIVER
00842048144960Navigated Short Open Screw Driver, Solid
00842048144953Navigated Short Open Screw Driver, Cannulated
00842048144946Navigated Short Reduction Screw Driver, Solid
00842048144939Navigated Short Reduction Screw Driver, Cannulated
00842048155355Navigated Modular Screw Driver, T25, Solid
00842048155348Navigated Modular Screw Driver, T25, Cannulated

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