FDA.reportPublic FDA data

GPC

Primary DI
08905892018121
Brand
GPC
Company
GPC MEDICAL LIMITED
Model
MLTN08-10T
Device description
intraHEAL Multi Angle Tibial Nail - Titanium, Dia. 8 mm, 340 mm Length
Published
2023-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories
JDSNail, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
JDSNail, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143245000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143245000GPC Intramedullary Nailing SystemsGpc Medical Limited2015-09-30HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08905892018121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08905892018121089058920181218905892018121

GMDN Terms#

Term, Definition table
TermDefinition
Arthrodesis nail, fixed-lengthA rod of fixed-length (i.e., not intended for distraction) intended to be implanted into the intramedullary canal of any long bone [e.g., femur, tibia, humerus (including fixation of the glenoid), talus, fibula, radius, ulna] for the purpose of joint fusion or arthrodesis; it is not dedicated to femur or tibia implantation. The device is used for traumatic repair or reconstructive procedures; it may include screws if locked into place. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9205302602info@gpcmedical.com

Regulatory Flags#

DUNS number
915882579
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
08905892010033GPCPFA10.17T2025-09-19
08905892042751GPCECPFAT2025-09-19
08905892042959GPCECMTT2025-09-19
08905892105418GPC848.06T2025-09-10
08905892105425GPC848.07T2025-09-10
08905892105432GPC848.08T2025-09-10
08905892105449GPC848.09T2025-09-10
08905892105456GPC848.10T2025-09-10
08905892105463GPC848.11T2025-09-10
08905892105470GPC848.11T2025-09-10
08905892105487GPC848.14T2025-09-10
08905892105494GPC848.16T2025-09-10
08905892105500GPC848.18T2025-09-10
08905892105616GPC849.06T2025-09-10
08905892105623GPC849.07T2025-09-10
08905892105630GPC849.08T2025-09-10
08905892105647GPC849.09T2025-09-10
08905892105654GPC849.10T2025-09-10
08905892105661GPC849.11T2025-09-10
08905892105678GPC849.12T2025-09-10

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