FDA.reportPublic FDA data

ELITE MEDICAL INSTRUMENTATION

Primary DI
G569EMI7081050
Brand
ELITE MEDICAL INSTRUMENTATION
Company
ELITE MEDICAL INSTRUMENTATION
Model
EMI-70-8105
Catalog number
EMI-70-8105 SPINAL CURETTE
Device description
"Currette, Spinal, Gorilla, 15"", Size 3"
Published
2024-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZSCurette, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G569EMI7081050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
116733674
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G569EMIMD4700ELITE MEDICAL INSTRUMENTATIONEMI-MD470EMI-MD470 BABCOCK CLAMP2024-05-16
G569EMIBB074R0ELITE MEDICAL INSTRUMENTATIONEMI-BB074REMI-BB074R KNIFE HANDLE2024-03-22
G569EMIBB077R0ELITE MEDICAL INSTRUMENTATIONEMI-BB077REMI-BB077R KNIFE HANDLE2024-03-22
G569EMIBC547R0ELITE MEDICAL INSTRUMENTATIONEMI-BC547REMI-BC547R SCISSORS2024-03-22
G569EMIBC557R0ELITE MEDICAL INSTRUMENTATIONEMI-BC557REMI-BC557R SCISSORS2024-03-22
G569EMIBC648R0ELITE MEDICAL INSTRUMENTATIONEMI-BC648REMI-BC648R SCISSORS2024-03-22
G569EMIBC677R0ELITE MEDICAL INSTRUMENTATIONEMI-BC677REMI-BC677R SCISSORS2024-03-22
G569EMIBM004R0ELITE MEDICAL INSTRUMENTATIONEMI-BM004REMI-BM004R NEEDLE HOLDER2024-03-22
G569EMIBM047R0ELITE MEDICAL INSTRUMENTATIONEMI-BM047REMI-BM047R NEEDLE HOLDER2024-03-22
G569EMIBM055R0ELITE MEDICAL INSTRUMENTATIONEMI-BM055REMI-BM055R NEEDLE HOLDER2024-03-22
G569EMIBM058R0ELITE MEDICAL INSTRUMENTATIONEMI-BM058REMI-BM058R NEEDLE HOLDER2024-03-22
G569EMIBM066R0ELITE MEDICAL INSTRUMENTATIONEMI-BM066REMI-BM066R NEEDLE HOLDER2024-03-22
G569EMIBT470R0ELITE MEDICAL INSTRUMENTATIONEMI-BT470REMI-BT470R RETRACTOR2024-03-22
G569EMIBT611R0ELITE MEDICAL INSTRUMENTATIONEMI-BT611REMI-BT611R RETRACTOR2024-03-22
G569EMIBT614R0ELITE MEDICAL INSTRUMENTATIONEMI-BT614REMI-BT614R RETRACTOR2024-03-22
G569EMIBT756R0ELITE MEDICAL INSTRUMENTATIONEMI-BT756REMI-BT756R RETRACTOR2024-03-22
G569EMIBT763R0ELITE MEDICAL INSTRUMENTATIONEMI-BT763REMI-BT763R2024-03-22
G569EMIKTS1040ELITE MEDICAL INSTRUMENTATIONEMI-KTS1-04EMI-KTS1-04 SPECULUM2024-03-22
G569EMI3535350ELITE MEDICAL INSTRUMENTATIONEMI-35-3535EMI-35-3535 CLAMP2024-03-21
G569EMI3536310ELITE MEDICAL INSTRUMENTATIONEMI-353631EMI-353631 CLAMP2024-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18257200087426ALIF DISC PREP,ALLOQUENT - ALIFOrthofix US LLCFZS2026-07-17
18257200104093ALLOQUENT - ALIFOrthofix US LLCFZS2026-07-17
B382SD9147092060Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092120Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092130Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147092140Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096450Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096460Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096470Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096510Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096520Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096530Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096540Surgical DirectSurgical Direct, Inc.FZS2026-07-09
B382SD9147096550Surgical DirectSurgical Direct, Inc.FZS2026-07-09
07640139342119ROMEO 2 INSTRUMENTATIONSpineArt SAFZS2025-11-10
04046963939588NOVOCARTAesculap AGFZS2020-04-24
04046963315511NOVOCARTAesculap AGFZS2020-04-23
04046963315528NOVOCARTAesculap AGFZS2020-04-23
10649111094002SklarSKLAR CORPORATIONFZS2019-08-26
10649111094088SklarSKLAR CORPORATIONFZS2019-08-26
10649111217210SklarSKLAR CORPORATIONFZS2019-03-15
10649111217494SklarSKLAR CORPORATIONFZS2019-03-15
10649111017711SklarSKLAR CORPORATIONFZS2019-03-13
10649111017858SklarSKLAR CORPORATIONFZS2019-03-13
10649111018084SklarSKLAR CORPORATIONFZS2019-03-13
10649111018282SklarSKLAR CORPORATIONFZS2019-03-13
10649111018619SklarSKLAR CORPORATIONFZS2019-03-13
10649111161612SklarSKLAR CORPORATIONFZS2019-03-13
10649111161964SklarSKLAR CORPORATIONFZS2019-03-13
10649111162060SklarSKLAR CORPORATIONFZS2019-03-13