FDA.reportPublic FDA data

Nivo

Primary DI
08964003163549
Brand
Nivo
Company
B. Ali Impex
Model
NCPL317
Device description
College Cotton Plier Self Locking Tweezers 317, 6”
Published
2024-01-29
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
EFLForceps, Dressing, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFLForceps, Dressing, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08964003163549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08964003163549089640031635498964003163549

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, tweezers-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It typically has a tweezers-like design with two blades joined at the proximal (non-working) end with variously designed tips at the working end. It is made of metal and/or plastic materials and is available in various sizes. 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

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G149NP380750NPSACME ENTERPRISE.EFL2026-05-01
G149NPRMF0NPSACME ENTERPRISE.EFL2026-05-01
00371347023503Advance Dental ProductsThe Atlanta Dental Supply CompanyEFL2026-04-14
ESAM3851141STOMA®Storz am Mark GmbHEFL2026-03-25
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B382SD9029931200Surgical DirectSurgical Direct, Inc.EFL2026-03-09
G1493807407TBS DentalACME ENTERPRISE.EFL2026-03-02
G1493807508TBS DentalACME ENTERPRISE.EFL2026-03-02
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B382SD9028532000Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9028532510Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9028541010Surgical DirectSurgical Direct, Inc.EFL2026-02-04
00841013120718Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120725Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120732Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06