FDA.reportPublic FDA data

KIATO PLUS

Primary DI
28902895180095
Brand
KIATO PLUS
Company
ADITYA DISPOMED PRODUCTS PRIVATE LIMITED
Model
10A
Catalog number
18009
Device description
KIATO PLUS Sterile Carbon steel Surgical Blade box of 100 size 10A. Sterilized by Gamma irradiation.
Published
2024-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
08902895180091PrimaryGS10
28902895180095Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08902895180091089028951800918902895180091
2890289518009528902895180095

GMDN Terms#

Term, Definition table
TermDefinition
Manual scalpel blade, single-useAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
675711147
Device count
100
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08902895129212KIATO PLUS21129212024-12-09
08902895129229KIATO PLUS22129222024-12-09
08902895129236KIATO PLUS23129232024-12-09
08902895129243KIATO PLUS24129242024-12-09
08902895129281KIATO PLUS25129282024-12-09
08902895129373KIATO PLUSSC129372024-12-09
08902895148091KIATO10A148092024-12-09
08902895148107KIATO10148102024-12-09
08902895148114KIATO11148112024-12-09
08902895148121KIATO12148122024-12-09
08902895148138KIATO13148132024-12-09
08902895148251KIATO12d148252024-12-09
08902895148312KIATO11P148312024-12-09
28902895129216KIATO PLUS21129212024-12-09
28902895129223KIATO PLUS22129222024-12-09
28902895129230KIATO PLUS23129232024-12-09
28902895129247KIATO PLUS24129242024-12-09
28902895129285KIATO PLUS25129282024-12-09
28902895129377KIATO PLUSSC129372024-12-09
28902895148095KIATO10A148092024-12-09

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