FDA.reportPublic FDA data

CONVERTORS

Primary DI
50192253038420
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
9447
Catalog number
9447
Device description
EENT Split Sheet, Large
Published
2020-11-18
Public version status
Update
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
ERYDrape, surgical, ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERYDrape, Surgical, EntGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253038420PackageGS18In Commercial Distribution
10192253038422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225303842050192253038420
1019225303842210192253038422

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-useA noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube). 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
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
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885380189883CONVERTORSCardinal Health 200, LLCERY2024-02-28
50195594968302CARDINAL HEALTHCardinal Health 200, LLCERY2021-04-15
00860005664009Isolaer Aerosol Isolation BarrierInquis Medical, Inc.ERY2021-02-03
50888439905555CARDINAL HEALTHCardinal Health 200, LLCERY2020-10-12
50888439772416CARDINAL HEALTHCardinal Health 200, LLCERY2020-05-11
50888439793848CARDINAL HEALTHCardinal Health 200, LLCERY2020-04-08
50885380176416CONVERTORSCardinal Health 200, LLCERY2019-12-13
50885380133549CONVERTORSCardinal Health 200, LLCERY2019-09-24
50888439381311CARDINAL HEALTHCardinal Health 200, LLCERY2019-03-12
50885380169289CARDINAL HEALTHCardinal Health 200, LLCERY2019-01-22
50885380164406CARDINAL HEALTHCardinal Health 200, LLCERY2018-11-28
50885380161016CONVERTORSCardinal Health 200, LLCERY2018-03-01
50885380160538CONVERTORSCardinal Health 200, LLCERY2018-02-08
50885380117884CONVERTORSCardinal Health 200, LLCERY2018-01-17
50885380139008CONVERTORSCardinal Health 200, LLCERY2017-09-28
50885380140493CONVERTORSCardinal Health 200, LLCERY2017-09-28
50885380152618CONVERTORSCardinal Health 200, LLCERY2017-07-24
00854427007124HEPRO. US General Pack - 10 Pouches-CaseHEPRO.US INC.ERY2017-06-21
00854427007988HEPRO.US Welcome Pack - CaseHEPRO.US INC.ERY2017-06-21
00854427007070HEPRO.US Surgical Scrub Suit 50pcs per CaseHEPRO.US INC.ERY2017-06-20
00854427007889HEPRO.US General Pack 1 PouchHEPRO.US INC.ERY2017-06-20
00854427007896HEPRO.US Welcome PackHEPRO.US INC.ERY2017-06-20
00854427007926HEPRO.US Surgical/Examination Suit MHEPRO.US INC.ERY2017-06-20
50885380062306CONVERTORSCardinal Health 200, LLCERY2016-07-08
50885380069428CONVERTORSCardinal Health 200, LLCERY2016-07-08
50630140029392CONVERTORSCardinal Health 200, LLCERY2016-06-28
50885380058385CONVERTORSCardinal Health 200, LLCERY2016-06-28
50885380109513CONVERTORSCardinal Health 200, LLCERY2016-06-22
50885380009486CONVERTORSCardinal Health 200, LLCERY2016-06-22
50885380047686CONVERTORSCardinal Health 200, LLCERY2016-06-22