FDA.reportPublic FDA data

CONVERTORS

Primary DI
50885380157934
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
39019N
Catalog number
39019N
Device description
SmartGown Breathable Surgical Gown, Large X-Long
Published
2019-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
FYAGOWN, SURGICAL
LROGeneral surgery tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2
LROGeneral Surgery TrayGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380157934PrimaryGS10
10885380157936Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538015793450885380157934
1088538015793610885380157936

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/examination garment kitA collection of apparel items intended to be worn by healthcare staff during a patient examination or surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. It consists of one or more of the following types of items (which may be worn over a scrub suit): gowns, aprons, shoe covers, sleeve covers, caps, drapes, gloves and surgical face masks. It may in addition include items intended to be worn by the patient to prevent cross-contamination, and hand sanitizing products (e.g., alcohol gel). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
961027315
Device count
20
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
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
00849233017276Busse Hospital DisposablesROBERT BUSSE & CO., INC.LRO2026-05-28
10809160522059HalyardAVID MEDICAL, INC.LRO2026-05-28
10809160522073HalyardAVID MEDICAL, INC.LRO2026-05-28
10809160522080HalyardAVID MEDICAL, INC.LRO2026-05-28
10885632522079SurgiTrackSMOWENS & MINOR DISTRIBUTION, INC.LRO2026-05-28
10653160393702MEDLINEMEDLINE INDUSTRIES, INC.LRO2026-05-27
10653160393757CENTURIONCENTURION MEDICAL PRODUCTS CORPORATIONLRO2026-05-27
10809160521878HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521885HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521892HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521922HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521939HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521946HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521953HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521960HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521977HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160521991HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522004HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522011HalyardAVID MEDICAL, INC.LRO2026-05-27
10809160522028HalyardAVID MEDICAL, INC.LRO2026-05-27
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