FDA.reportPublic FDA data

Nivo

Primary DI
08964003163365
Brand
Nivo
Company
B. Ali Impex
Model
NEX17
Device description
Excavator #17Spoon
Published
2024-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EKCExcavator, Dental, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKCExcavator, Dental, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08964003163365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08964003163365089640031633658964003163365

GMDN Terms#

Term, Definition table
TermDefinition
Dental excavator, reusableA hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645802117
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08964003163853Doctor Nice786-28L102024-01-29
08964003163860Doctor Nice786-30L102024-01-29
08964003163877Doctor Nice786-04G32024-01-29
08964003163884Doctor Nice786-04L2024-01-29
08964003163891Doctor Nice786-03L2024-01-29
08964003163075Doctor Nice786-14786-142023-11-10
08964003163112Doctor Nice786-14G42023-11-10
08964003163129Doctor Nice786-33G22023-11-10
08964003163136Doctor Nice786-34G22023-11-10
08964003163143Doctor Nice786-14G52023-11-10
08964003163020Doctor Nice786-012023-11-09
08964003163037Doctor Nice786-022023-11-09
08964003163051Doctor Nice786-032023-11-09
08964003163068Doctor Nice786-152023-11-09
08964003163082Doctor Nice786-15/G22023-11-09
08964003163099Doctor Nice786-14/G22023-11-09
08964003163105Doctor Nice786-15G42023-11-09
08964003163150Doctor Nice786-04LB2023-11-09
08964003163167Doctor Nice786-282023-11-09
08964003163174Doctor Nice786-302023-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898506841585QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843282QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843299QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843305QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843763QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843770QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506843787QuinelatoSchobell Industrial LtdaEKC2022-12-08
07898506851799QuinelatoSchobell Industrial LtdaEKC2022-12-08
10889950010065HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010072HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010089HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
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10889950010102HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010119HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010126HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010133HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010140HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010157HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010164HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010171HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010188HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010195HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010201HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010218HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010225HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010232HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010249HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010256HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010263HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12
10889950010270HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKC2020-11-12