FDA.reportPublic FDA data

PERLA NAV

Primary DI
07640221373618
Brand
PERLA NAV
Company
SpineArt SA
Model
NAV-IN 33 90-N
Catalog number
NAV-IN 33 90-N
Device description
PERLA TL NAV. LOCKING SCREWDRIVER, MS-PS
Published
2026-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640221373618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640221373618076402213736187640221373618

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
483016148
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640221373021PERLA NAVNAV-IN 11 50-NNAV-IN 11 50-N2026-05-07
07640221373038PERLA ® TLHAN-FI BA 50-N2026-05-07
07640221373045PERLA ® TLTLF-IN 01 60-N2026-05-07
07640221373052PERLA NAVNAV-IN 43 30-NNAV-IN 43 30-N2026-05-07
07640221373069PERLA NAVNAV-IN 43 60-NNAV-IN 43 60-N2026-05-07
07640221373076PERLA ® TLTLF-IN 03 70-N2026-05-07
07640221373083PERLA ® TLTLF-IN 12 00-N2026-05-07
07640221373090PERLA ® TLTLF-IN 04 70-N2026-05-07
07640221373113PERLA NAVNAV-IN 41 75-NNAV-IN 41 75-N2026-05-07
07640221373120PERLA NAVNAV-IN 41 80-NNAV-IN 41 80-N2026-05-07
07640221373137PERLA NAVNAV-IN 41 85-NNAV-IN 41 85-N2026-05-07
07640221373144PERLA NAVNAV-IN 41 90-NNAV-IN 41 90-N2026-05-07
07640221373151PERLA NAVNAV-IN 41 95-NNAV-IN 41 95-N2026-05-07
07640221373168PERLA NAVNAV-IN 41 00-NNAV-IN 41 00-N2026-05-07
07640221373175PERLA NAVNAV-IN 41 05-NNAV-IN 41 05-N2026-05-07
07640221373182PERLA NAVNAV-IN 41 10-NNAV-IN 41 10-N2026-05-07
07640221373199PERLA NAVNAV-IN 41 15-NNAV-IN 41 15-N2026-05-07
07640221373205PERLA NAVNAV-IN 41 20-NNAV-IN 41 20-N2026-05-07
07640221373212PERLA NAVNAV-IN 41 25-NNAV-IN 41 25-N2026-05-07
07640221373229PERLA NAVNAV-IN 42 70-NNAV-IN 42 70-N2026-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810131882433ION-C Navigation LocatorSurgentec, LLCOLO2026-07-06
00810131882440Ion Navigation Drill Bit - 5.0mmSurgentec, LLCOLO2026-07-06
00810131882457Ion Navigation Drill Bit - 5.5mmSurgentec, LLCOLO2026-07-06
00810131882464Ion Navigation Drill Bit - 4.5mmSurgentec, LLCOLO2026-07-06
00810131882532TiLink-L Navigation Drill Bit - 8mmSurgentec, LLCOLO2026-07-06
00810131882556TiLink-L Navigation Drill GuideSurgentec, LLCOLO2026-07-06
00810131882563TiLink-L Navigation Inserter Hexalobe DriverSurgentec, LLCOLO2026-07-06
00810131882617TiLink-L Navigation Impact CapSurgentec, LLCOLO2026-07-06
00810131883270ION-C Navigation Drill Guide - AdjustableSurgentec, LLCOLO2026-07-06
00810131883669Ion Navigation Inserter AOSurgentec, LLCOLO2026-07-06
00810131884871ION-C Navigation Reusable TraySurgentec, LLCOLO2026-07-06
00810131884970ION-C Navigation Reusable Tray AssemblySurgentec, LLCOLO2026-07-06
10705034647845TRIALTISMedos International SàrlOLO2026-07-04
10705034647852TRIALTISMedos International SàrlOLO2026-07-04
10705034647883TRIALTISMedos International SàrlOLO2026-07-04
00840493423166RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423173RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423180RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423197RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423203RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423210RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423227RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423234RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423241RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423258RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423265RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423272RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423289RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423296RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08
00840493423302RIVA Pedicle Screw SystemXENIX MEDICAL LLCOLO2026-06-08