ROMEO 2 INSTRUMENTATION DEGEN NAV-IN 10 40-N

GUDID 07640185341333

Nav. Tap

SpineArt SA

Bone tap, reusable
Primary Device ID07640185341333
NIH Device Record Key964557c0-8608-463d-a41f-e95001f204f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameROMEO 2 INSTRUMENTATION DEGEN
Version Model NumberNAV-IN 10 40-N
Catalog NumberNAV-IN 10 40-N
Company DUNS483016148
Company NameSpineArt SA
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter
Outer Diameter4 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107640185341333 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


[07640185341333]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-21
Device Publish Date2019-06-13

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