FDA.reportPublic FDA data

Not Applicable

Primary DI
18904233122975
Brand
Not Applicable
Company
NIRAJ INDUSTRIES PRIVATE LIMITED
Model
#20
Catalog number
02297
Device description
STAINLESS STEEL NON STERILE SCALPEL (SURGICAL BLADE WITH PLASTIC HANDLE & COVER) #20 BULK PACKED MYCO REORDER # 6000CST-20
Published
2020-07-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
28904233122972PackageGS1250In Commercial Distribution
58904233122973PackageGS11000In Commercial Distribution
18904233122975PrimaryGS10
08904233122978Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2890423312297228904233122972
5890423312297358904233122973
1890423312297518904233122975
08904233122978089042331229788904233122978

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
650191174
Device count
25
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
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