FDA.reportPublic FDA data

Not Applicable

Primary DI
58904233117979
Brand
Not Applicable
Company
NIRAJ INDUSTRIES PRIVATE LIMITED
Model
#10
Catalog number
01797
Device description
STAINLESS STEEL NON STERILE SURGICAL BLADE # 10 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
58904233117979PackageGS110000In Commercial Distribution
18904233117971PrimaryGS10
08904233117974Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5890423311797958904233117979
1890423311797118904233117971
08904233117974089042331179748904233117974

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
08904233151916TECHNOCUT#15CA051912023-11-17
28904233150845GLASS VAN#84050842023-08-01
28904233116438GLASS VAN#10A016432020-07-01
28904233116544GLASS VAN#24016542020-07-01
58904233117207Not Applicable#172017202020-07-01
58904233117214Not Applicable#172017212020-07-01
58904233117375TECHNO CUT#11017372020-07-01
58904233117382TECHNO CUT#12017382020-07-01
28904233117404Not Applicable#11017402020-07-01
28904233117411Not Applicable#15017412020-07-01
28904233117428Not Applicable#22017422020-07-01
58904233117665TECHNO CUT#10017662020-07-01
58904233117672TECHNO CUT#12B017672020-07-01
58904233117689TECHNO CUT#15C017682020-07-01
58904233117696TECHNO CUT#15017692020-07-01
58904233117702TECHNO CUT#22017702020-07-01
58904233117719TECHNO CUT#20017712020-07-01
58904233117726TECHNO CUT#21017722020-07-01
58904233117733TECHNO CUT#23017732020-07-01
58904233117740TECHNO CUT#24017742020-07-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327651119VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651126VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651140VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651157VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651171VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651195VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651201VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651218VersiQuadSTRYKER CORPORATIONGES2026-07-16
07613327651225VersiQuadSTRYKER CORPORATIONGES2026-07-16
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