FDA.reportPublic FDA data

TECHNO CUT

Primary DI
18904233117674
Brand
TECHNO CUT
Company
HMD HEALTHCARE INDIA PRIVATE LIMITED
Model
#12B
Catalog number
01767
Device description
TECHNO CUT STAINLESS STEEL STERILE SCALPEL (SURGICAL BLADE WITH PLASTIC HANDLE & COVER) #12B INDIVIDUALLY PACKED MYCO REORDER # 6008T-12B
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
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
58904233117672PackageGS11000In Commercial Distribution
18904233117674PrimaryGS10
08904233117677Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
5890423311767258904233117672
1890423311767418904233117674
08904233117677089042331176778904233117677

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.

Regulatory Flags#

DUNS number
650191174
Device count
10
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
false

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
18904233117414Not Applicable#15017412020-07-01
18904233117421Not Applicable#22017422020-07-01
18904233117667TECHNO CUT#10017662020-07-01
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
00810055255184Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255191Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255207Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255214Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255238Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255245Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255252Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255269Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255276Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255283Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255290Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255313Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255320Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255337Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255368Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255382Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255429Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255436Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255443Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255450Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255467Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255474Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255511Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255528Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255535Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255542Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255559Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255566Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255580Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255597Surgical DesignSurgical Design, Inc.GES2026-09-26