Curette

GUDID 03760418040247

Curette

SC MEDICA

Internal spinal fixation procedure kit, reusable
Primary Device ID03760418040247
NIH Device Record Key882f35d1-10bc-4877-a309-1f1eb960db32
Commercial Distribution StatusIn Commercial Distribution
Brand NameCurette
Version Model Number57.006.24
Company DUNS267135902
Company NameSC MEDICA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103760418040247 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


[03760418040247]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-21
Device Publish Date2024-11-13

Devices Manufactured by SC MEDICA

03760418040162 - FFX instruments tray2024-11-21 An instrument tray for FFX device implantation is a sterilizable container that securely holds and organizes surgical instrument
03760418040179 - FFX holder2024-11-21 Holder for FFX with tips
03760418040186 - Impactor2024-11-21 Impactor for FFX with tips
03760418040193 - Facet chisel2024-11-21 Straight facet chisel with titanium handle
03760418040209 - Rasp2024-11-21 Rasp with titanium handle
03760418040216 - Graft holder2024-11-21 Graft holder - 5 mm height
03760418040223 - Implant trial 11x 2.52024-11-21 Implant trial with tip size 11x2.5
03760418040230 - Implant trial 11x 32024-11-21 Implant trial with tip size 11x3

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