FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10197106680599
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
07-0110A
Catalog number
07-0110A
Device description
WINGED SPONGE KIT
Published
2024-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GECBRUSH, SCRUB, OPERATING-ROOM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GECBrush, Scrub, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50197106680597PackageGS150In Commercial Distribution
10197106680599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710668059750197106680597
1019710668059910197106680599

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253072723Curity8441268441262026-10-08
10192253072730Curity8441368441362026-10-08
10192253072747Curity8441468441462026-10-08
10192253072754Curity8441568441562026-10-08
10192253072761Curity8441668441662026-10-08
10192253072778Curity8441768441762026-10-08
10192253072785Curity8442168442162026-10-08
10192253072792Curity8442268442262026-10-08
10192253072808Curity8442368442362026-10-08
10192253072815Curity8442468442462026-10-08
10192253072822Curity8442568442562026-10-08
10885380207150Curity4100A4100A2026-10-08
10885380207167Curity4101A4101A2026-10-08
10885380207174Curity4102A4102A2026-10-08
50885380207202Curity41000410002026-10-08
50885380207219Curity4103A4103A2026-10-08
50885380207226Curity4104A4104A2026-10-08
50885380207233Curity4105A4105A2026-10-08
50885380207240Curity42000420002026-10-08
50885380207257Curity43000430002026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10620974004551Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-05-19
10620974004568Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-05-19
10620974001338Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-01-07
10620974004506Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-01-07
10620974004513Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-01-07
10620974004520Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-01-07
10620974004537Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-01-07
10620974004322Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004339Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004346Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004353Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004360Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004377Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004384Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
10620974004391Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004325Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004332Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004349Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004356Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004363Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004370Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004387Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00620974004394Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2025-08-28
00194613045883MSI Precision Specialty InstrumentsMed Saver, Inc.GEC2025-08-01
00194613115708MSI Precision Specialty InstrumentsMed Saver, Inc.GEC2025-08-01
00194613116101MSI Precision Specialty InstrumentsMed Saver, Inc.GEC2025-08-01
00194613116118MSI Precision Specialty InstrumentsMed Saver, Inc.GEC2025-08-01
0066641611231980000 Series Reusable General and Rigid Cleaning BrushPrimed Instruments IncGEC2025-06-13