FDA.reportPublic FDA data

Nivo

Primary DI
08964003163334
Brand
Nivo
Company
B. Ali Impex
Model
NE5DE
Device description
Explorer #5 (#17/23) DE
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
EKBExplorer, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKBExplorer, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08964003163334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08964003163334089640031633348964003163334

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical probe, reusableA slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. 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
G149TBSB2010TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2020TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2030TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2040TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB2050TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3010TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3020TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3030TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3040TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3050TBS BASICSACME ENTERPRISE.EKB2026-05-16
G149TBSB3060TBS BASICSACME ENTERPRISE.EKB2026-05-16
10889950002916HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010027HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010034HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010041HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010058HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010799HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010805HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010812HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010829HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010836HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010843HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010850HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010867HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010874HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010881HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010898HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010904HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010911HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12
10889950010928HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKB2020-11-12