FDA.report

GPC

Primary DI
08904400204384
Brand
GPC
Company
GPC MEDICAL LIMITED
Model
IRF1295R
Device description
Bushing, S.S.
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

Related Records

Contact Domains

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08904400204384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08904400204384089044002043848904400204384

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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 DIBrandModelCatalogPublished
08904400203394GPCGOS1439S2025-09-19
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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

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