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
10198956101524CARDINAL HEALTHSOP73TKAPBSOP73TKAPB2026-06-03
10198956177055CARDINAL HEALTHPBCGPVWTIPBCGPVWTI2026-06-03
10198956198456CARDINAL HEALTHSMA69OMBFFSMA69OMBFF2026-06-03
10198956309012CARDINAL HEALTHMAT534227DMAT534227D2026-06-03
10198956320086CARDINAL HEALTHSOP73HESJESOP73HESJE2026-06-03
10198956320123CARDINAL HEALTHPV63ADSTIPV63ADSTI2026-06-03
10198956328938CARDINAL HEALTHSCV3ICVJCDSCV3ICVJCD2026-06-03
10198956332638CARDINAL HEALTHSOP52AC52ASOP52AC52A2026-06-03
10198956334915CARDINAL HEALTHSANCGCARIFSANCGCARIF2026-06-03
10198956346369CARDINAL HEALTHSCVCGEPSBBSCVCGEPSBB2026-06-03
10198956348950CARDINAL HEALTHSBA4LMNGRESBA4LMNGRE2026-06-03
10198956362147CARDINAL HEALTHSOP73KPIODSOP73KPIOD2026-06-03
10198956363922CARDINAL HEALTHSEN41FPVVDSEN41FPVVD2026-06-03
10198956371040CARDINAL HEALTHSOP56KAOSHSOP56KAOSH2026-06-03
10198956372641CARDINAL HEALTHSOP43ARANBSOP43ARANB2026-06-03
10198956379008CARDINAL HEALTHSOP45CAGHISOP45CAGHI2026-06-03
10198956385689CARDINAL HEALTHSOP44TKSVCSOP44TKSVC2026-06-03
10198956386099CARDINAL HEALTHSMA56IVRCBSMA56IVRCB2026-06-03
10198956390928CARDINAL HEALTHSBA54LCTCCSBA54LCTCC2026-06-03
10198956391437CARDINAL HEALTHSOT42SPMSESOT42SPMSE2026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10620974004483Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-05-19
10620974004490Southmedic Instrument Cleaning BrushesSouthmedic IncorporatedGEC2026-05-19
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