FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439381313
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SNE38HDSVA
Catalog number
SNE38HDSVA
Device description
HEAD DRAPE PACK
Published
2019-03-12
Public version status
Update
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
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
50888439381311PackageGS115In Commercial Distribution
10888439381313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843938131150888439381311
1088843938131310888439381313

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
No natural rubber latex
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
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
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