FDA.reportPublic FDA data

Not Applicable

Primary DI
58904233118297
Brand
Not Applicable
Company
NIRAJ INDUSTRIES PRIVATE LIMITED
Model
#60
Catalog number
01829
Device description
STAINLESS STEEL NON STERILE SURGICAL BLADE # 60 BULK PACKED
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
58904233118297PackageGS15000In Commercial Distribution
18904233118299PrimaryGS10
08904233118292Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5890423311829758904233118297
1890423311829918904233118299
08904233118292089042331182928904233118292

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
200
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
00840456201701JMUJMU DENTAL, INCGES2026-06-22
00840456201718JMUJMU DENTAL, INCGES2026-06-22
00840456201725JMUJMU DENTAL, INCGES2026-06-22
00840456201732JMUJMU DENTAL, INCGES2026-06-22
00840456201749JMUJMU DENTAL, INCGES2026-06-22
00840456203170JMUJMU DENTAL, INCGES2026-06-22
00840456203187JMUJMU DENTAL, INCGES2026-06-22
00840456203194JMUJMU DENTAL, INCGES2026-06-22
00840456203200JMUJMU DENTAL, INCGES2026-06-22
00840456203217JMUJMU DENTAL, INCGES2026-06-22
00840456215692JMUJMU DENTAL, INCGES2026-06-22
00840456215708JMUJMU DENTAL, INCGES2026-06-22
00840456215715JMUJMU DENTAL, INCGES2026-06-22
00840456215722JMUJMU DENTAL, INCGES2026-06-22
00840456215920JMUJMU DENTAL, INCGES2026-06-22
00840456215937JMUJMU DENTAL, INCGES2026-06-22
00840456215944JMUJMU DENTAL, INCGES2026-06-22
00840456215951JMUJMU DENTAL, INCGES2026-06-22
00840456215968JMUJMU DENTAL, INCGES2026-06-22
00840456215982JMUJMU DENTAL, INCGES2026-06-22
00840456215999JMUJMU DENTAL, INCGES2026-06-22
00840456216002JMUJMU DENTAL, INCGES2026-06-22
00840456220641JMUJMU DENTAL, INCGES2026-06-22
00840456220658JMUJMU DENTAL, INCGES2026-06-22
00840456220665JMUJMU DENTAL, INCGES2026-06-22
00840456220672JMUJMU DENTAL, INCGES2026-06-22
00840456220689JMUJMU DENTAL, INCGES2026-06-22
00840456220696JMUJMU DENTAL, INCGES2026-06-22
00840456220702JMUJMU DENTAL, INCGES2026-06-22
00840456220719JMUJMU DENTAL, INCGES2026-06-22