FDA.reportPublic FDA data

Not Applicable

Primary DI
58904233122980
Brand
Not Applicable
Company
NIRAJ INDUSTRIES PRIVATE LIMITED
Model
#11
Catalog number
02298
Device description
STAINLESS STEEL NON STERILE SURGICAL BLADE # 11 BARREL POLISHED BULK PACKED MYCO REORDER # 3000-11
Published
2020-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
58904233122980PackageGS110000In Commercial Distribution
18904233122982PrimaryGS10
08904233122985Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5890423312298058904233122980
1890423312298218904233122982
08904233122985089042331229858904233122985

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel blade, single-useA sterile 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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
650191174
Device count
500
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18904233151913TECHNOCUT#15CA051912023-11-17
08904233151916TECHNOCUT#15CA051912023-11-17
18904233150848GLASS VAN#84050842023-08-01
28904233150845GLASS VAN#84050842023-08-01
18904233116431GLASS VAN#10A016432020-07-01
18904233116547GLASS VAN#24016542020-07-01
18904233117209Not Applicable#172017202020-07-01
18904233117216Not Applicable#172017212020-07-01
18904233117971Not Applicable#10017972020-07-01
18904233117988Not Applicable#11017982020-07-01
18904233118107TECHNO CUT#10018102020-07-01
18904233118114TECHNO CUT#11018112020-07-01
18904233118121TECHNO CUT#12018122020-07-01
18904233118145TECHNO CUT#15018142020-07-01
18904233118152TECHNO CUT#20018152020-07-01
18904233118169TECHNO CUT#21018162020-07-01
18904233118176TECHNO CUT#22018172020-07-01
18904233118183TECHNO CUT#23018182020-07-01
18904233118190TECHNO CUT#24018192020-07-01
18904233118282Not Applicable#22018282020-07-01

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
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08902895180206KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
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08902895182200KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06
08902895182217KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGES2024-12-06