FDA.reportPublic FDA data

Kendall

Primary DI
50192253051870
Brand
Kendall
Company
Cardinal Health 200, LLC
Model
139093
Catalog number
139093
Device description
Scalpel
Published
2024-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
50192253051870PackageGS1100In Commercial Distribution
10192253051872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225305187050192253051870
1019225305187210192253051872

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
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
false
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
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25
10198956354517CARDINAL HEALTHSOP44TSTODSOP44TSTOD2026-05-25
10198956358003CARDINAL HEALTHSOT53CYPZDSOT53CYPZD2026-05-25
10198956358904CARDINAL HEALTHSOP53ACVLFSOP53ACVLF2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850069257030LumohsNANO SURGICAL, INCGDX2026-02-20
36945630141820STERiLANCESterilance Medical (Suzhou) Inc.GDX2026-02-05
00850057092998HexaHexa DentalGDX2026-01-21
36945630137588index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630137595index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630137601index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630137618index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630139063index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
36945630139070index AsuritySterilance Medical (Suzhou) Inc.GDX2025-08-26
00194613018825MSI Precision Specialty InstrumentsMed Saver, Inc.GDX2025-08-01
00642356001425Mastel Precision Surgical Instruments, Inc.Mastel Surgical Inc.GDX2025-07-08
00642356001432Mastel Precision Surgical Instruments, Inc.Mastel Surgical Inc.GDX2025-07-08
00642356001449Mastel Precision Surgical Instruments, Inc.Mastel Surgical Inc.GDX2025-07-08
00810111224482Scalpel Treace Medical Concepts, Inc.GDX2025-05-06
00810111224543Scalpel Treace Medical Concepts, Inc.GDX2025-03-25
36945630135805BardSterilance Medical (Suzhou) Inc.GDX2025-03-21
06945630114083BardSterilance Medical (Suzhou) Inc.GDX2025-02-28
05063043035045Swann Morton Ltd.SWANN-MORTON LIMITEDGDX2024-12-27
05063043036042Swann Morton Ltd.SWANN-MORTON LIMITEDGDX2024-12-27
20197344025197MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
20197344025203MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
20197344025210MEDLINEMEDLINE INDUSTRIES, INC.GDX2024-12-24
28902895129216KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129223KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129230KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129247KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129285KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895129377KIATO PLUSADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895148095KIATOADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09
28902895148101KIATOADITYA DISPOMED PRODUCTS PRIVATE LIMITEDGDX2024-12-09