FDA.reportPublic FDA data

GPC

Primary DI
08905892039560
Brand
GPC
Company
GPC MEDICAL LIMITED
Model
ILB39.58T
Device description
Locking Bolt 3.9 mm - Titanium
Published
2025-09-19
Public version status
New
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
HWCScrew, Fixation, Bone

Product Code Classifications#

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

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
08905892039560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08905892039560089058920395608905892039560

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
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
00841731132918REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132925REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03
00841731132932REDEMPTION Beaming SystemVILEX LLCHWC2026-11-03