FDA.reportPublic FDA data

CONVERTORS

Primary DI
10885380109515
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
29422
Catalog number
29422
Device description
Thyroid Sheet
Published
2016-06-22
Public version status
Update
Distribution status
Not 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
50885380109513PackageGS110Not in Commercial Distribution
10885380109515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538010951350885380109513
1088538010951510885380109515

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 or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.

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
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

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
50885380169289CARDINAL HEALTHCardinal Health 200, LLCERY2019-01-22
50885380164406CARDINAL HEALTHCardinal Health 200, LLCERY2018-11-28
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10885380138997CONVERTORSCardinal Health 200, LLCERY2017-11-07
10885380141515CONVERTORSCardinal Health 200, LLCERY2017-09-28
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50885380140493CONVERTORSCardinal Health 200, LLCERY2017-09-28
50885380152618CONVERTORSCardinal Health 200, LLCERY2017-07-24
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00854427007988HEPRO.US Welcome Pack - CaseHEPRO.US INC.ERY2017-06-21