FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106040018
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SER11RT11E
Catalog number
SER11RT11E
Device description
REMOVAL TRAY
Published
2022-12-05
Public version status
New
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
MCZSuture removal kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCZSuture Removal KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106040018PackageGS19In Commercial Distribution
10197106040010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710604001850197106040018
1019710604001010197106040010

GMDN Terms#

Term, Definition table
TermDefinition
Suture removal kitA collection of various sterile instruments, dressings, and pharmaceuticals designed to remove sutures from a patient. It typically includes a disinfectant, scissors, forceps, gauze and bandages. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
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
50198956326871CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-03-16
50198956228991CARDINAL HEALTHCardinal Health 200, LLCMCZ2026-02-09
20809160508470Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.MCZ2026-01-09
20809160507602Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.MCZ2026-01-06
10849233014296Busse Hospital DisposablesROBERT BUSSE & CO., INC.MCZ2025-12-29
00850063139458Neil Medical Group Neil Medical GroupMCZ2025-12-08
00850063139465Neil Medical Group Neil Medical GroupMCZ2025-12-08
50198956254778CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-12-02
50198956260038CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-11-13
50198956160437CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-08-28
20809160486228Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.MCZ2025-07-16
50198956112481CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-07-09
05010058185784InstrapacROBINSON HEALTHCARE LIMITEDMCZ2025-06-25
05010058178458InstrapacROBINSON HEALTHCARE LIMITEDMCZ2025-06-23
50198956057928CARDINAL HEALTHCardinal Health 200, LLCMCZ2025-06-05
50628725005374SUTURE REMOVAL KITCanadian Hospital Specialties LimitedMCZ2025-06-02
10661392000152LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392000169LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392000916LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001739LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001760LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001777LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001784LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001821LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001845LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001869LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001890LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001913LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392001999LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16
10661392002002LSL HEALTHCARELSL Industries, LLCMCZ2025-05-16