FDA.reportPublic FDA data

Not Applicable

Primary DI
18904233117414
Brand
Not Applicable
Company
HMD HEALTHCARE INDIA PRIVATE LIMITED
Model
#15
Catalog number
01741
Device description
STAINLESS STEEL NON STERILE SCALPEL (SURGICAL BLADE WITH PLASTIC HANDLE & COVER) #15 BULK PACKED MYCO REORDER # 6000CST-15
Published
2020-07-01
Public version status
Update
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
28904233117411PackageGS1250In Commercial Distribution
58904233117412PackageGS11000In Commercial Distribution
18904233117414PrimaryGS10
08904233117417Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2890423311741128904233117411
5890423311741258904233117412
1890423311741418904233117414
08904233117417089042331174178904233117417

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
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
18904233116431GLASS VAN#10A016432020-07-01
18904233116547GLASS VAN#24016542020-07-01
18904233117209Not Applicable#172017202020-07-01
18904233117216Not Applicable#172017212020-07-01
18904233117377TECHNO CUT#11017372020-07-01
18904233117384TECHNO CUT#12017382020-07-01
18904233117407Not Applicable#11017402020-07-01
18904233117421Not Applicable#22017422020-07-01
18904233117667TECHNO CUT#10017662020-07-01
18904233117674TECHNO CUT#12B017672020-07-01
18904233117681TECHNO CUT#15C017682020-07-01
18904233117698TECHNO CUT#15017692020-07-01
18904233117704TECHNO CUT#22017702020-07-01
18904233117711TECHNO CUT#20017712020-07-01
18904233117728TECHNO CUT#21017722020-07-01
18904233117735TECHNO CUT#23017732020-07-01
18904233117742TECHNO CUT#24017742020-07-01
18904233117971Not Applicable#10017972020-07-01
18904233117988Not Applicable#11017982020-07-01
18904233118107TECHNO CUT#10018102020-07-01

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