FDA.reportPublic FDA data

Cinesteam®

Primary DI
03665851000097
Brand
Cinesteam®
Company
CEMAG CARE
Model
114810
Catalog number
114810
Device description
Cinesteam® is a non-adhesive secondary dressing designed to absorb exudates and eliminate unpleasant odours. It consists of an absorbent layer together with a sachet containing cinnamon.Composition: polyethylene, polyester, polypropylene and cinnamon.
Published
2026-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NACDressing, Wound, Hydrophilic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NACDressing, Wound, HydrophilicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665851000097PrimaryGS10
03665851000110Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665851000097036658510000973665851000097
03665851000110036658510001103665851000110

GMDN Terms#

Term, Definition table
TermDefinition
Odour-absorbent dressing, non-antimicrobialA covering for malodourous wounds or lesions (e.g., venous leg ulcers, fungating carcinomas, infected surgical wounds), that absorbs the bad odours typically through a layer of activated charcoal; it does not include an antimicrobial agent(s). Given the types of wounds to which it is typically applied, the device may also contain a layer that absorbs heavy exudates, and one that minimizes adherence to the wound. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7.5Inch
Width4Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+33158281683contact@cemagcare.com
+33158281683contact@cinesteamcare.com

Regulatory Flags#

DUNS number
267809035
Device count
12
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665851000103Cinesteam®1149101149102026-01-01
03665851000110Cinesteam®1148101148102026-01-01
03665851000127Cinesteam®1149101149102026-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937935316927Sacral Silicone Superabsorbent DressingShanghai Iso Medical Products Co., Ltd.NAC2026-08-03
06979191881955OKTAPEHTT Technologies, Inc.NAC2026-07-31
06979191881962OKTAPEHTT Technologies, Inc.NAC2026-07-31
06979191881979OKTAPEHTT Technologies, Inc.NAC2026-07-31
06979191882280NanacareWAL-MART STORES, INC.NAC2026-07-31
06974692681561GUANGYIJiangsu Guangyi Medical Dressing Co.,LTD.NAC2026-07-22
01714196634404HydraLock SA with BorderSion Brands LLCNAC2026-07-16
01714196635500HydraLock SA with BorderSion Brands LLCNAC2026-07-16
01714196637702HydraLock SA with BorderSion Brands LLCNAC2026-07-16
10197344175963MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
10197344175970MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
10197344175987MEDLINEMEDLINE INDUSTRIES, INC.NAC2026-07-13
00850088144314CARBOUNingbo kehu Medical Technology Co.,Ltd.NAC2026-07-08
00197344111513CURADMEDLINE INDUSTRIES, INC.NAC2026-07-03
00197998001727Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295812Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295850Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295898Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00197998295942Solventum™ Kerracel™Solventum US LLCNAC2026-06-27
00810178889921ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889938ViveCareVIVE HEALTH LLCNAC2026-05-29
00810178889945ViveCareVIVE HEALTH LLCNAC2026-05-29
00850087488433CeeportCEEPORT INC.NAC2026-05-29
00850087488440CeeportCEEPORT INC.NAC2026-05-29
00850087488518CeeportCEEPORT INC.NAC2026-05-29
09551031940007DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940014DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940021DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940038DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22
09551031940045DODODOTSDODO VENTURES SDN. BHD.NAC2026-04-22