FDA.report

FX Solutions®

Primary DI
03701037313756
Brand
FX Solutions®
Company
FX SOLUTIONS
Model
902-0342
Catalog number
902-0342
Device description
IMPACTOR BIT Ø42mm
Published
2021-02-17
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

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03701037313756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03701037313756037010373137563701037313756

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store away from light and sunlight Store away from moisture

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
263076196
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
false
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
03701037311776Humelock II926-10412025-08-01
03701037311783Humelock II926-10422025-08-01
03701037311790Humelock II926-10432025-08-01
03701037311806Humelock II926-10442025-08-01
03701037311813Humelock II926-10452025-08-01
03701037316450FX V135951-89032025-08-01
03701037321133Humelock Reversed961-00032025-08-01
03701037321140Humelock Reversed Shoulder906-00502025-08-01
03701037319512Full wedge baseplates951-01072025-06-13
03701037318669FX V135 Shoulder Prosthesis951-52102025-04-09
03701037318676FX V135 Shoulder Prosthesis951-52122025-04-09
03701037318683FX V135 Shoulder Prosthesis951-54102025-04-09
03701037318690FX V135 Shoulder Prosthesis951-54122025-04-09
03701037318706FX V135 Shoulder Prosthesis951-54142025-04-09
03701037318713FX V135 Shoulder Prosthesis951-56122025-04-09
03701037318737FX V135 Shoulder Prosthesis951-56162025-04-09
03701037318652FX V135 Shoulder Prosthesis951-52082025-04-07
03701037320426EasyTech Anatomical910-0130-CM12025-03-03
03701037320532Humelock II603-00172025-03-03
03701037321010FX V135911-2051911-20512025-02-20

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