FDA.reportPublic FDA data

KOSMA-KARE

Primary DI
10770619270381
Brand
KOSMA-KARE
Company
Kosma-Kare Canada Inc
Model
KC-2289
Device description
COTTON COIL 16G/Y - 22LBS / CS
Published
2020-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FRLFiber, Medical, Absorbent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10770619270381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1077061927038110770619270381

GMDN Terms#

Term, Definition table
TermDefinition
Cotton pleatsA device designed as an absorbent, non-sterile mass of cotton or man-made fibres formed in a band of zigzag folds (pleats) and used for a variety of applications such as, absorbing or removing fluid/liquid from various parts of the body or for cosmetic purposes in the home. It is used within the healthcare sector or the home and is normally available [non-prescription] over-the-counter (OTC). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
248955460
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196027651PINCOMAM111CS2020-10-30
10080196035700PINCOMAM222CS2020-10-30
10080196127740PINCOMAM55CS2020-10-30
40080196027652PINCOMAM111CS2020-10-30
40080196035701PINCOMAM222CS2020-10-30
40080196127741PINCOMAM55CS2020-10-30
10770619270305KOSMA-KAREJ-22772020-10-16
10770619270312KOSMA-KAREJ-22782020-10-16
10770619270329KOSMA-KAREJ-22792020-10-16
10770619270336KOSMA-KAREJ-22812020-10-16
10770619270343KOSMA-KAREJ-22882020-10-16
10770619270350KOSMA-KAREKC-22812020-10-16
10770619270367KOSMA-KAREKC-22872020-10-16
10770619270374KOSMA-KAREKC-22882020-10-16
10770619270398KOSMA-KAREKC-22902020-10-16
10770619270404KOSMA-KAREKC-22922020-10-16
10770619270411KOSMA-KAREKB-22882020-10-16
10770619270428KOSMA-KAREKB-22892020-10-16
00770619270162ZINO5BZL40012020-10-16
00770619270179ZINO5BZL30012020-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10814707025023CygnusASPEN SURGICAL PRODUCTS, INC.FRL2026-04-10
10850018327982MHMazza Healthcare LLCFRL2026-04-09
16931918102054HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918103969HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918107936HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918100913HALYARDGRI Medical & Electronic Technology Co., Ltd.FRL2025-09-17
10193489001907MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-08-06
10653160341628CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFRL2025-07-06
10197106935132CARDINAL HEALTHCardinal Health 200, LLCFRL2025-02-24
10810178830135Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830142Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830159Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830166Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830173Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830180Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10653160382928MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-01-15
10193489009460REMEDYMEDLINE INDUSTRIES, INC.FRL2024-10-24
10193489012521MEDLINEMEDLINE INDUSTRIES, INC.FRL2024-10-24
10850049784402SURGYCOSurgyco LLCFRL2023-12-15
10850049784419SURGYCOSurgyco LLCFRL2023-12-15
10810132041843HCSConcordance Healthcare Solutions LLCFRL2023-10-16
10884389108949MedlineMEDLINE INDUSTRIES, INC.FRL2023-10-12
10850054813203Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-28
10850054813241Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-28
10850054813289Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-28
10850054813296Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813302Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813319Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813098Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-12
10850054813104Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-12