FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380169289
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
9442NA
Catalog number
9442NA
Device description
EENT Split Sheet, Absorbent reinforcement, adhesive, Nonsterile
Published
2019-01-22
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
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
50885380169289PrimaryGS10
10885380169281Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538016928950885380169289
1088538016928110885380169281

GMDN Terms#

Term, Definition table
TermDefinition
Patient surgical drape, single-use, non-sterileA non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
961027315
Device count
540
Premarket exempt
true
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
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50885380189881CONVERTORSCardinal Health 200, LLCERY2024-02-28
10885380189883CONVERTORSCardinal Health 200, LLCERY2024-02-28
10195594968304CARDINAL HEALTHCardinal Health 200, LLCERY2021-04-15
50195594968302CARDINAL HEALTHCardinal Health 200, LLCERY2021-04-15
00860005664009Isolaer Aerosol Isolation BarrierInquis Medical, Inc.ERY2021-02-03
10192253038422CONVERTORSCardinal Health 200, LLCERY2020-11-18
50192253038420CONVERTORSCardinal Health 200, LLCERY2020-11-18
10888439905557CARDINAL HEALTHCardinal Health 200, LLCERY2020-10-12
50888439905555CARDINAL HEALTHCardinal Health 200, LLCERY2020-10-12
10888439772418CARDINAL HEALTHCardinal Health 200, LLCERY2020-05-11
50888439772416CARDINAL HEALTHCardinal Health 200, LLCERY2020-05-11
10888439793840CARDINAL HEALTHCardinal Health 200, LLCERY2020-04-08
50888439793848CARDINAL HEALTHCardinal Health 200, LLCERY2020-04-08
50885380176416CONVERTORSCardinal Health 200, LLCERY2019-12-13
50885380133549CONVERTORSCardinal Health 200, LLCERY2019-09-24
10888439381313CARDINAL HEALTHCardinal Health 200, LLCERY2019-03-12
50888439381311CARDINAL HEALTHCardinal Health 200, LLCERY2019-03-12
50885380164406CARDINAL HEALTHCardinal Health 200, LLCERY2018-11-28
50885380161016CONVERTORSCardinal Health 200, LLCERY2018-03-01
50885380160538CONVERTORSCardinal Health 200, LLCERY2018-02-08
10885380117886CONVERTORSCardinal Health 200, LLCERY2018-01-17
50885380117884CONVERTORSCardinal Health 200, LLCERY2018-01-17
10885380138997CONVERTORSCardinal Health 200, LLCERY2017-11-07
10885380141515CONVERTORSCardinal Health 200, LLCERY2017-09-28
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