FDA.reportPublic FDA data

GPC

Primary DI
08905892004704
Brand
GPC
Company
GPC MEDICAL LIMITED
Model
MLFN09-12L
Device description
intraHEALMulti Angle Femoral Nail - S.S. - Left, Dia. 10 mm, 360 mm Length
Published
2024-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBRod, Fixation, Intramedullary And Accessories
HTYPin, Fixation, Smooth
HWCScrew, Fixation, Bone
JDSNail, Fixation, Bone
JDWPin, Fixation, Threaded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HTYPin, Fixation, SmoothOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDSNail, Fixation, BoneOrthopedic2
JDWPin, Fixation, ThreadedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203811000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203811000GPC Intraheal Intramedullary Nailing SystemGpc Medical Limited2022-02-10HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08905892004704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08905892004704089058920047048905892004704

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
09353903030461OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-11-04
09353903030478OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-11-04
09353903030485OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTY2026-11-04
00841731132642REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132659REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132666REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132673REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132680REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132697REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132703REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132710REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132727REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132734REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132741REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132758REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132765REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132772REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132789REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132796REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132802REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132819REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132826REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132833REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132840REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132857REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132864REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132871REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132888REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132895REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132901REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03