FDA.reportPublic FDA data

CONVERTORS

Primary DI
50885380100718
Brand
CONVERTORS
Company
Cardinal Health 200, LLC
Model
43241MNS
Catalog number
43241MNS
Device description
Spine Lap Drape BNS
Published
2016-06-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
KKXDrape, surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKXDrape, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380100718PrimaryGS10
10885380100710Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538010071850885380100718
1088538010071010885380100710

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
12
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
10885380184895CARDINAL HEALTH82021820212024-07-25
10885380184901CARDINAL HEALTH82022820222024-07-25
10885380184918CARDINAL HEALTH82023820232024-07-25
10885380184925CARDINAL HEALTH82024820242024-07-25
50885380004818CONVERTORS9423N9423N2016-06-21
50885380009837CONVERTORS29455NA29455NA2016-06-21
50885380016972CONVERTORS29557N29557N2016-06-21
50885380020016CONVERTORS9450N9450N2016-06-21
50885380027916CONVERTORS9441N9441N2016-06-21
50885380030619CONVERTORS29444N29444N2016-06-21
50885380034068CONVERTORS29527N29527N2016-06-21
50885380034402CONVERTORS29559N29559N2016-06-21
50885380036116CONVERTORS9449N9449N2016-06-21
50885380053755CONVERTORS29421NB29421NB2016-06-21
50885380053779CONVERTORS9438NB9438NB2016-06-21
50885380053854CONVERTORS29465NB29465NB2016-06-21
50885380053878CONVERTORS29467NB29467NB2016-06-21
50885380053892CONVERTORS29522NB29522NB2016-06-21
50885380053922CONVERTORS9430NB9430NB2016-06-21
50885380053939CONVERTORS9458NB9458NB2016-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056646500291Basic Implant SetOMNIA SRLKKX2026-03-27
08056646500307Implantology SetOMNIA SRLKKX2026-03-27
08056646500321Oral Surgery SetOMNIA SRLKKX2026-03-27
08056646500482Oral Surgery PackOMNIA SRLKKX2026-03-27
10080196176700Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496648Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496655Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196496686Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497164Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497171Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497188Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497195Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497720Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196497744Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498239Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498376Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498673Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196498772Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2023-07-29
10080196025893MEDLINEMEDLINE INDUSTRIES, INC.KKX2022-10-03
10080196496563Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2022-03-20
10080196496662Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2022-03-20
10080196497713Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KKX2022-03-20
10080196007134MedlineMEDLINE INDUSTRIES, INC.KKX2021-09-22
10080196311033MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KKX2021-03-16
10080196325825MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KKX2021-03-16
10080196333950MedlineMEDLINE INDUSTRIES, INC.KKX2021-03-16
10080196571932MedlineMEDLINE INDUSTRIES, INC.KKX2021-01-26
10080196744213MedlineMEDLINE INDUSTRIES, INC.KKX2020-11-11
10080196748150MedlineMEDLINE INDUSTRIES, INC.KKX2020-11-10
10080196747115MedlineMEDLINE INDUSTRIES, INC.KKX2020-11-09