PERLA TL MIS NAV-Instruments NAV-IN 36 10-N

GUDID 07640450868824

PERLA TL NAV. CANNULATED TAP Ø10.0 (Ø10.5 SCREW)

SpineArt SA

Bone tap, reusable
Primary Device ID07640450868824
NIH Device Record Key8cd4a60a-444c-4bac-a149-e5a74538394b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePERLA TL MIS NAV-Instruments
Version Model NumberNAV-IN 36 10-N
Catalog NumberNAV-IN 36 10-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 Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter
Outer Diameter10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107640450868824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


[07640450868824]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-06
Device Publish Date2021-03-29

On-Brand Devices [PERLA TL MIS NAV-Instruments]

07640450868886PERLA TL NAV. CORTICAL SCREWDRIVER TUBE
07640450868855PERLA TL NAV LOCKING SCREWDRIVER XTAB
07640450868848PERLA TL NAV. SCREWDRIVER XTAB
07640450868831PERLA TL NAV. CANNULATED TAP Ø10.5
07640450868824PERLA TL NAV. CANNULATED TAP Ø10.0 (Ø10.5 SCREW)
07640450868817PERLA TL NAV. CANNULATED TAP Ø9.5
07640450868800PERLA TL NAV. CANNULATED TAP Ø9.0 (Ø9.5 SCREW)
07640450868794PERLA TL NAV. CANNULATED TAP Ø8.5
07640450868787PERLA TL NAV. CANNULATED TAP Ø8.0 (Ø8.5 SCREW)
07640450868770PERLA TL NAV. CANNULATED TAP Ø7.5
07640450868763PERLA TL NAV. CANNULATED TAP Ø7.0 (Ø7.5 SCREW)
07640450868756PERLA TL NAV. CANNULATED TAP Ø6.5
07640450868749PERLA TL NAV. CANNULATED TAP Ø6.0 (Ø6.5 SCREW)
07640450868732PERLA TL NAV. CANNULATED TAP Ø5.5
07640450868725PERLA TL NAV. CANNULATED TAP Ø5.0 (Ø5.5 SCREW)
07640450868718PERLA TL NAV. ADJUSTABLE DRILL GUIDE

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