FDA.reportPublic FDA data

GPC

Primary DI
08904400202427
Brand
GPC
Company
GPC MEDICAL LIMITED
Model
GOS1433
Device description
Instrument Set for intraHEAL Proximal Femoral Nail, Advanced/ Instrument Set for Proximal Femoral Nail, Advanced
Published
2024-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08904400202427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08904400202427089044002024278904400202427

GMDN Terms#

Term, Definition table
TermDefinition
General external orthopaedic fixation system implantation kit, reusableA collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. This is a reusable 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08904400203394GPCGOS1439S2025-09-19
08904400208689GPCIBP637.0452025-09-19
08904400210903GPC900.15.012025-09-19
08904400210927GPC900.15.032025-09-19
08904400210934GPC900.15.042025-09-19
08904400210941GPC900.15.052025-09-19
08904400210958GPC900.15.062025-09-19
08904400211351GPCBTD1130.25.1802025-09-19
08904400211412GPCBTD1130.32.1952025-09-19
08904400211443GPCBTD1130.35.2002025-09-19
08904400211481GPCBTD1130.45.1952025-09-19
08904400224139GPCS-HS-SD1434.452025-09-19
08904400224245GPCS-HS-SD1434.652025-09-19
08905892010033GPCPFA10.17T2025-09-19
08905892010040GPCPFA10.20T2025-09-19
08905892010057GPCPFA10.24T2025-09-19
08905892010064GPCPFA11.17T2025-09-19
08905892010071GPCPFA11.20T2025-09-19
08905892010088GPCPFA11.24T2025-09-19
08905892010095GPCPFA12.17T2025-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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