FDA.report

CONVERTORS

Primary DI
50630140918641
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
29428N
Catalog number
29428N
Device description
Side Sheet BNS
Published
2016-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KKXDrape, surgical
PUIDrape, surgical, exempt

Product Code Classifications

CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50630140918641PrimaryGS10
10630140918643Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5063014091864150630140918641
1063014091864310630140918643

GMDN Terms

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
Ethylene Oxide

Regulatory Flags

DUNS number
961027315
Device count
55
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
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
50198956219043CARDINAL HEALTHSBA29BRCCFSBA29BRCCF2026-03-24
50198956219401CARDINAL HEALTHSOT29UR87ESOT29UR87E2026-03-24
50198956220513CARDINAL HEALTHSOT29CPCCDSOT29CPCCD2026-03-24
50198956220643CARDINAL HEALTHSCV29MN87ESCV29MN87E2026-03-24
50198956278484CARDINAL HEALTHSOPCNPPRVCSOPCNPPRVC2026-03-24
50198956284980CARDINAL HEALTH34-8041H34-8041H2026-03-24
50198956285987CARDINAL HEALTHSBACNLSMBGSBACNLSMBG2026-03-24
50198956300116CARDINAL HEALTH17C4553C17C4553C2026-03-24
50198956300499CARDINAL HEALTHSAN12BSSUJSAN12BSSUJ2026-03-24
50198956302929CARDINAL HEALTHSOP32SHFLKSOP32SHFLK2026-03-24
50198956306866CARDINAL HEALTHSBAOCBLCPCSBAOCBLCPC2026-03-24
50198956307986CARDINAL HEALTHSOP21EPSCGSOP21EPSCG2026-03-24
50198956308006CARDINAL HEALTHSOP21KPSCJSOP21KPSCJ2026-03-24
50198956311372CARDINAL HEALTHPVCGCGAUFPVCGCGAUF2026-03-24
50198956314687CARDINAL HEALTHSMAHDGVAAGSMAHDGVAAG2026-03-24
50198956322897CARDINAL HEALTHSEN1DNSUNNSEN1DNSUNN2026-03-24
50198956327939CARDINAL HEALTHSBACGMPACFSBACGMPACF2026-03-24
50198956328851CARDINAL HEALTHSANCGRPILCSANCGRPILC2026-03-24
50198956334760CARDINAL HEALTHSBACGHERIFSBACGHERIF2026-03-24
50198956335569CARDINAL HEALTHSNE19NSKHRSNE19NSKHR2026-03-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00849296004916Welmed, Inc.WELMED INC.PUI2026-03-20
20748426264487Medline-MicrotekMicrotek Medical LLCPUI2026-03-16
20748426264494Medline-MicrotekMicrotek Medical LLCPUI2026-03-16
10748426264503Medline-MicrotekMicrotek Medical LLCPUI2026-03-16
00634916019353Standard SupremeSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916120905Instrument HolderSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916781373WrapPel Table CoverSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916870633Instrument DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916881202Circumcision Drape,STANDARD TEXTILE CO., INC.PUI2026-03-11
00634916881226Split DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916881233T-Lap Fenestrated DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
16975424198736Proficient SurgicalEXACT MEDICAL MANUFACTURING, INC.KKX2026-03-11
00812564036025MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036070MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036100MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036186MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036193MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036216MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
00812564036384MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10080196017010MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277636729MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277660946MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277660953MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10884389185780MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-11
10888277635555MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
10888277357037MedlineMEDLINE INDUSTRIES, INC.KKX2026-03-10
04052199810164Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
04052199810188Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
04052199810201Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
26975424198832Exact Medical Manufacturing, Inc.EXACT MEDICAL MANUFACTURING, INC.KKX2026-03-09