FDA.reportPublic FDA data

CONVERTORS

Primary DI
10885380038082
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
29556
Catalog number
29556
Device description
Tiburon XL Angiography Drape W/Expanded Reinforcement
Published
2016-06-28
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
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380038080PackageGS18Not in Commercial Distribution
10885380038082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538003808050885380038080
1088538003808210885380038082

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
false
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
10198956106666CARDINAL HEALTHSAN23PMPRHSAN23PMPRH2026-10-23
10198956201606CARDINAL HEALTHPOV2ASNULPOV2ASNUL2026-10-23
10198956318748CARDINAL HEALTHSAN42RPIRBSAN42RPIRB2026-10-23
10198956332553CARDINAL HEALTHPNVNNECHVPNVNNECHV2026-10-23
10198956409552CARDINAL HEALTHSCV40CVKUGSCV40CVKUG2026-10-23
10198956433113CARDINAL HEALTHSEN40EPWEDSEN40EPWED2026-10-23
10198956460942CARDINAL HEALTHSBA69BPSABSBA69BPSAB2026-10-23
10198956463417CARDINAL HEALTHPB41GLLAEPB41GLLAE2026-10-23
10198956487918CARDINAL HEALTHSOPHDTPMSCSOPHDTPMSC2026-10-23
10198956504899CARDINAL HEALTHSNE12CRKGOSNE12CRKGO2026-10-23
10198956505766CARDINAL HEALTHSOPCNARCRESOPCNARCRE2026-10-23
10198956506572CARDINAL HEALTHSOT7ECPSSESOT7ECPSSE2026-10-23
10198956508682CARDINAL HEALTHSOP53TPNABSOP53TPNAB2026-10-23
10198956530157CARDINAL HEALTHSAN11IRLVLSAN11IRLVL2026-10-23
10198956530799CARDINAL HEALTH34-0748B34-0748B2026-10-23
10198956534834CARDINAL HEALTHSANOCCCPOFSANOCCCPOF2026-10-23
10198956544123CARDINAL HEALTHPG08GMPCBPG08GMPCB2026-10-23
10198956548923CARDINAL HEALTHSNE33SPMACSNE33SPMAC2026-10-23
10198956549524CARDINAL HEALTHSBA11LYMMJSBA11LYMMJ2026-10-23
10198956553552CARDINAL HEALTHSOP41TPSGGSOP41TPSGG2026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00618125192502Ziehm ImagingTIDI PRODUCTS, LLCPUI2026-10-22
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08684382977451SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
08684382999712SUBMEDSU BIYOMEDIKAL SISTEMLER VE SAGLIK HIZMETLERI SANAYI VE TICARET ANONIM SIRKETIPUI2026-10-20
00850067913238SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913245SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913252SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
00850067913269SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
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00850067913283SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-16
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00850067913092SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913108SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913115SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913122SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913139SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913146SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913153SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913160SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913191SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913214SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
00850067913221SteriGear®HR PHARMACEUTICALS INC.PUI2026-10-15
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10192253072242CONVERTORSCardinal Health 200, LLCPUI2026-10-14
10192253072259CONVERTORSCardinal Health 200, LLCPUI2026-10-14
20193489029946MedlineMEDLINE INDUSTRIES, INC.PUI2026-10-14
20748426264531Medline-MicrotekMicrotek Medical LLCPUI2026-10-14