FDA.reportPublic FDA data

Nivo

Primary DI
08964003163563
Brand
Nivo
Company
B. Ali Impex
Model
NKHC55
Device description
Kelly Hemostat Curved 5.5”
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
EMDHemostat, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMDHemostat, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08964003163563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08964003163563089640031635638964003163563

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. 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
G149TBSB7410TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7420TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7430TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7440TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7450TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7460TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7470TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7480TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149TBSB7490TBS BASICSACME ENTERPRISE.EMD2026-05-21
G149NP380760NPSACME ENTERPRISE.EMD2026-05-01
G1493806608TBS DentalACME ENTERPRISE.EMD2026-03-02
G1493807609TBS DentalACME ENTERPRISE.EMD2026-03-02
08800075610102OSUNG MNDOSUNG MND Co., Ltd.EMD2025-11-03
00841336101630Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMD2025-09-28
00841336101647Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMD2025-09-28
D928140052DLC0HEMOSTAT JACKSON, SLIGHT CURVED, DLC, 19 CMW.H. Holden, Inc.EMD2025-06-24
00840343726287GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343726379GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343726386GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343726393GEN2SURGIX MEDICAL LLCEMD2025-06-09
00840343725884GEN2SURGIX MEDICAL LLCEMD2025-03-07
00842517111417Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
00842517111424Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
00842517112209Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
00842517112216Karl SchumacherKarl Schumacher Dental, LLCEMD2025-02-05
D928140051190HEMOSTAT CRAFOORD SLIGHT CURVED 19CMW.H. Holden, Inc.EMD2024-12-18
00840343725099GEN2SURGIX MEDICAL LLCEMD2024-11-07
00840343724702GEN2SURGIX MEDICAL LLCEMD2024-10-25
00840343724061GEN2SURGIX MEDICAL LLCEMD2024-10-01
00840343724078GEN2SURGIX MEDICAL LLCEMD2024-10-01