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
04260223630224curea P1curea medical GmbHNAC2026-09-27
04260223630231curea P1curea medical GmbHNAC2026-09-27
04260223630248curea P1curea medical GmbHNAC2026-09-27
04260223630255curea P1curea medical GmbHNAC2026-09-27
04260223630262curea P1curea medical GmbHNAC2026-09-27
04260223630279curea P1curea medical GmbHNAC2026-09-27
04260223630286curea P1 draincurea medical GmbHNAC2026-09-27
04260223630347curea P2curea medical GmbHNAC2026-09-27
04260223630378curea P2curea medical GmbHNAC2026-09-27
04260223630408curea P2curea medical GmbHNAC2026-09-27
04260223630422curea P2curea medical GmbHNAC2026-09-27
04260223630651curea P1curea medical GmbHNAC2026-09-27
04260223630668curea P2curea medical GmbHNAC2026-09-27
04260223630736curea P1curea medical GmbHNAC2026-09-27
04260223630880curea P1curea medical GmbHNAC2026-09-27
04260223630989curea P1 heelcurea medical GmbHNAC2026-09-27
04260223631184curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631191curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631207curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631214curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631368curea P1curea medical GmbHNAC2026-09-27
04260223631672curea P2curea medical GmbHNAC2026-09-27
04260223631696curea P2curea medical GmbHNAC2026-09-27
04260223631757curea P1 DUO activecurea medical GmbHNAC2026-09-27
04260223631771curea P2 activecurea medical GmbHNAC2026-09-27
04260223631795curea P2 activecurea medical GmbHNAC2026-09-27
04260223631849curea P2 activecurea medical GmbHNAC2026-09-27
04260223631931curea P1 easy bordercurea medical GmbHNAC2026-09-27
00749756401920DeRoyalDEROYAL INDUSTRIES, INC.NAC2026-09-18
00841277111286Novera SeamHarps USA, Inc.NAC2026-09-04