FDA.reportPublic FDA data

Nivo

Primary DI
08964003163440
Brand
Nivo
Company
B. Ali Impex
Model
NISC45
Device description
Iris Scissors Standard Curved 4.5”
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
EGNScissors, Surgical Tissue, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08964003163440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08964003163440089640031634408964003163440

GMDN Terms#

Term, Definition table
TermDefinition
Blepharoplasty scissorsA hand-held, manual, ophthalmic surgical instrument intended to be used to cut eyelid tissue during plastic surgery of the eyelids (blepharoplasty). It comprises two pivoted blades that usually have finger and thumb ring-handles, and which cut with a shearing action (i.e., the fine blades cut when the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs and sizes. It is not intended for intraocular surgery. This is a reusable device intended to be sterilized prior to use.

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
G149NPGFS0NPSACME ENTERPRISE.EGN2026-05-01
08961104625839MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625846MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625853MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625860MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625877MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625884MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625891MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625907MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625914MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625921MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625938MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625945MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625952MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625969MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625976MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625983MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104625990MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626003MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626010MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626027MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626034MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626041MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626058MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626096MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626102MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626119MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626126MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626133MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22
08961104626140MelpexMELPEX BEAUTY INSTRUMENTSEGN2026-04-22