FDA.reportPublic FDA data

Pectus Versa System

Primary DI
07901125600232
Brand
Pectus Versa System
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
LOCKING SCREW
Catalog number
371-25
Published
2026-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07901125600232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07901125600232079011256002327901125600232

GMDN Terms#

Term, Definition table
TermDefinition
Funnel chest remodelling barA non-sterile implantable device intended to be used to reduce the deformity of pectus excavatum (funnel chest) by applying outward force from a position deep to the sternum to reposition the sternum; it is typically used in paediatric patients and surgically removed when remodelling is evident (after 2-3 years). It is a thin curved bar, with or without serrations, made of metal [e.g., stainless steel, titanium (Ti)] that can be anchored with wires or with stabilizer plates laterally on the rib cage. This is a single-patient device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
900865213
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
07899258616506Orthopedic InstrumentsSYNDESMOSIS CLAMP314-1002026-07-07
07899258625348Orthopedic InstrumentsGUIDE WIRE Ø1.0x190.0mm WITHOUT THREAD106-812026-07-07
07899258625355Orthopedic Instruments1,0x190mm THREADED GUIDE WIRE106-822026-07-07
07899258633350Orthopedic InstrumentsGUIDE DRILL DOUBLE 2,7mm106-852026-07-07
07899258633367Orthopedic Instruments4.0mm CANCELLOUS TAP106-862026-07-07
07899258633374Orthopedic InstrumentsSMALL DEPTH GAUGE106-872026-07-07
07899258633381Orthopedic InstrumentsØ1.0x250.0mm WIRE106-882026-07-07
07899258634388Orthopedic InstrumentsSCREW EXTRACTOR 3.5mm169-4252026-07-07
07899258636290Orthopedic InstrumentsØ3.2mm WIRE CUTTING FORCEPS172-19A2026-07-07
07899258645094Orthopedic InstrumentsSCREW DRIVER TIP HEXALOBULAR T15 FIT AO307-1102026-07-07
07899258646527Orthopedic Instruments1.0x20.0x100.0mm GUIDE WIRE WITH SPHERICAL STOP223-3062026-07-07
07899258655864Orthopedic InstrumentsINSTRUMENTAL TRAY FOR ANKLE FRACTURE314-70022026-07-07
07899258655871Orthopedic InstrumentsIMPLANT TRAY TO ANKLE FRACTURE314-70042026-07-07
07899258655932Orthopedic InstrumentsVERSALOCK SYSTEM KIT FOR ANKLE314-70012026-07-07
07899258655949Orthopedic InstrumentsANKLE FRACTURE IMPLANT TRAY314-70032026-07-07
07899258656151Orthopedic InstrumentsIDENTIFICATION AND ORIENTATION PANEL314-70082026-07-07
07899258695464Orthopedic InstrumentsVERSA AND VERSALOCK SCREW CASES Ø2.7mm AND Ø3.5mm314-70052026-07-07
07899258695471Orthopedic InstrumentsMINI CANNULATED SCREW CASE Ø4.0mm AND DEDICATED IN314-70062026-07-07
07899258695488Orthopedic InstrumentsVERSALOCK MINI PLATE CASE314-70072026-07-07
07901125601130GMReis Suture AnchorsFASTLOCK - KNOTLESS PEEK ANCHOR Ø4.75x15.0/19.1mm 320-475191-PE3H2026-06-25

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