FDA.reportPublic FDA data

Kendall

Primary DI
10192253051834
Brand
Kendall
Company
Cardinal Health 200, LLC
Model
131611
Catalog number
131611
Device description
Scalpel
Published
2024-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GDXSCALPEL, ONE-PIECE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDXScalpel, One-PieceGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20192253051831PackageGS110In Commercial Distribution
50192253051832PackageGS110In Commercial Distribution
10192253051834PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225305183120192253051831
5019225305183250192253051832
1019225305183410192253051834

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, reusableA 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 device is typically made of high-grade stainless steel alloy. This is a reusable device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810111227346Scalpel Treace Medical Concepts, Inc.GDX2026-05-19
00850069257002LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257019LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257026LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257040LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257057LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257064LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257071LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257088LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257095LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257101LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257118LumohsNANO SURGICAL, INCGDX2026-04-29
00850069257033LumohsNANO SURGICAL, INCGDX2026-02-20
16945630141826STERiLANCESterilance Medical (Suzhou) Inc.GDX2026-02-05
00818788021892Epimed International, Inc.EPIMED INTERNATIONAL, INCGDX2025-11-21
16945630137584index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137591index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137607index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630137614index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630139069index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
16945630139076index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
10198459343490MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GDX2025-05-22
16945630114080BardSterilance Medical (Suzhou) Inc.GDX2025-02-28
10197344025190MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
10197344025206MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
10197344025213MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
08902895129212KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129229KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129236KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
08902895129243KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09