FDA.reportPublic FDA data

MANI DISPOSABLE VESSEL KNIFE

Primary DI
14546951370371
Brand
MANI DISPOSABLE VESSEL KNIFE
Company
MANI, INC.
Model
FDVKE500
Device description
MANI DISPOSABLE VESSEL KNIFE
Published
2022-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GESBLADE, SCALPEL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14546951370371PrimaryGS10
74546951370373Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1454695137037114546951370371
7454695137037374546951370373

GMDN Terms#

Term, Definition table
TermDefinition
Manual scalpel blade, single-useAn interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.

Regulatory Flags#

DUNS number
690622428
Device count
5
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14546951638990MANI Ophthalmic KnifeMSL16MV-02 Slit Angled 1.6mm2026-04-23
14546951618787MANI TRABECULOTOMY HOOKMTH-S TRABECULOTOMY HOOK Straight Type2026-04-29
04546951534219MANI CARBIDE BURS6 (CA)2026-04-08
04546951601447MANI CARBIDE BURS1/4 (CA)2026-04-08
04546951601454MANI CARBIDE BURS1/2 (CA)2026-04-08
04546951601461MANI CARBIDE BURS1 (CA)2026-04-08
04546951601478MANI CARBIDE BURS2 (CA)2026-04-08
04546951601485MANI CARBIDE BURS3 (CA)2026-04-08
04546951601492MANI CARBIDE BURS4 (CA)2026-04-08
04546951601508MANI CARBIDE BURS5 (CA)2026-04-08
04546951601515MANI CARBIDE BURS7 (CA)2026-04-08
04546951601522MANI CARBIDE BURS8 (CA)2026-04-08
04546951400729MANI Sutures Polyester337833782016-06-04
04546951400750MANI Sutures Polyester337533752016-06-04
04546951400767MANI Sutures Polyester337433742016-06-04
04546951400859MANI Sutures Polyester337333732016-06-04
04546951401429MANI Sutures Polyester141214122016-06-04
04546951402662MANI Sutures Polyester337133712016-06-04
04546951402679MANI Sutures Polyester337033702016-06-04
04546951400538MANI Sutures Polyester435743572016-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459343513MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GES2025-05-22
08717903490228Humeca blade for Silver knifeHumeca B.V.GES2025-05-20
08717903490242Humeca blade for Humby long knife (20cm/7.9 in)Humeca B.V.GES2025-05-20
08717903490235Humeca blade for Humby, Cobbett and Watson knives (16 cm/6.3 in)Humeca B.V.GES2025-05-19
10888277384224MEDLINEMEDLINE INDUSTRIES, INC.GES2025-02-14
10888277391857MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-30
10888277383395MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-29
10888277385115MEDLINEMEDLINE INDUSTRIES, INC.GES2025-01-29
10850053289818SurgycoSurgyco LLCGES2024-12-20
10850053289825SurgycoSurgyco LLCGES2024-12-20
10850053289832SurgycoSurgyco LLCGES2024-12-20
10850053289849SurgycoSurgyco LLCGES2024-12-20
10850053289856SurgycoSurgyco LLCGES2024-12-20
08902895180190KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895180206KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
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