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
00199536925007BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925014BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925021BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925038BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925045BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925052BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925069BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925076BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925083BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925090BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925106BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925113BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925120BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925137BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925144BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925151BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
00199536925168BluelineTransparent Supply Solutions Ltd.FRL2026-08-07
20197344219428MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219442MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219459MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219466MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219473MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219480MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219497MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219503MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-17
20197344219435MEDLINEMEDLINE INDUSTRIES, INC.FRL2026-07-13
10814707025023CygnusASPEN SURGICAL PRODUCTS, INC.FRL2026-04-10
10850018327982MHMazza Healthcare LLCFRL2026-04-09
10193489001907MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-08-06
10653160341628CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFRL2025-07-06