FDA.reportPublic FDA data

GMReis Fibula Nail System

Primary DI
07899258695075
Brand
GMReis Fibula Nail System
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
Left Fibula Nail 3,6x110mm
Catalog number
302-04US
Device description
Left Fibula Nail 3,6x110mm
Published
2025-06-24
Public version status
Update
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
HSBRod, Fixation, Intramedullary And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899258695075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899258695075078992586950757899258695075

GMDN Terms#

Term, Definition table
TermDefinition
Arthrodesis intramedullary nail, non-distractingA rigid rod, not intended for bone distraction, dedicated to arthrodesis/joint fusion through implantation into the intramedullary canal of a long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), fibula, radius, ulna] which extends beyond the joint to an adjacent bone(s), as part of traumatic repair or reconstructive procedures. It may be of fixed or variable length to allow compression (dynamic). It is intended to be fixed to the bone with screws which may be included with the nail. This is a single-use device.

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
07901125602533Expert KnotlessExpert KnotlessFD0010102026-05-28
07899258650500Orthopedic InstrumentsREDUCTION FORCEPS JAW169-1652026-05-19
07899258699943Orthopedic InstrumentsT7 HEXALOBULAR DRIVER TIP 95mm223-308-F2026-05-19
07901125602502Orthopedic InstrumentsFRESA PARA PLACA DORSAL STT180-3802026-05-13
07901125602519Orthopedic InstrumentsFRESA PARA PLACA DORSAL CHTL 12F180-3812026-05-13
07901125602526Orthopedic InstrumentsFRESA PARA PLACA DORSAL CHTL 8F180-3822026-05-13
07899258601847Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.4x11.0mm223-24-11-BP2026-04-08
07899258601854Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.4x13.0mm223-24-13-BP2026-04-08
07899258601861Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.4x15.0mm223-24-15-BP2026-04-08
07899258601878Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.4x11.0mm223-24-11-C2026-04-08
07899258601885Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.4x13.0mm223-24-13-C2026-04-08
07899258601892Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.4x15.0mm223-24-15-C2026-04-08
07899258601908Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.7x11.0mm223-27-11-BP2026-04-08
07899258601915Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.7x13.0mm223-27-13-BP2026-04-08
07899258601922Super Upper Limbs Versalock Plating SystemVERSALOCK LOCKING SCREW Ti T7 Ø2.7x15.0mm223-27-15-BP2026-04-08
07899258601939Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.7x11.0mm223-27-11-C2026-04-08
07899258601946Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.7x13.0mm223-27-13-C2026-04-08
07899258601953Super Upper Limbs Versalock Plating SystemVERSA TORXDRIVE MINI SCREW Ti Ø2.7x15.0mm223-27-15-C2026-04-08
07899258612546Super Upper Limbs Versalock Plating SystemVERSALOCK TORXDRIVE MINI SCREW T6 Ø2.0x15.0mm308-20-15-B2026-04-08
07899258663500Super Upper Limbs Versalock Plating SystemVERSALOCK RADIUS SHAFT PLATE, VOLAR 160.0mm180-1122026-04-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898624869669NEONAIL Neoortho Produtos Ortopédicos S/A.HSB2015-10-21
07898624869140NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869157NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869164NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869171NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869188NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869195NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869201NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869218NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869225NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869232NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869249NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869256NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869263NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869270NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869287NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869294NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869300NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869317NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869331NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869348NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869355NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869362NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869379NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869386NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869393NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869409NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869416NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869423NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06
07898624869430NEONAILNeoortho Produtos Ortopédicos S/A.HSB2015-10-06