FDA UDI
In Commercial Distribution
🇺🇸 United States
Cinesteam®
DI: 03665851000103
·
Model: 114910
·
CEMAG CARE
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Cinesteam®
- Primary DI
- 03665851000103
- Version / Model
- 114910
- Catalog Number
- 114910
- Company Name
- CEMAG CARE
- Labeler DUNS
- 267809035
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2026-01-01
- Public Version
- 1
- Public Version Date
- 2026-01-09
- Public Version Status
- New
- Public Device Record Key
- 4d05d754-0c94-4c35-9f80-1b5c7ee13dc4
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | 878.4018 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44897 | Odour-absorbent dressing, non-antimicrobial | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 03665851000127 | GS1 | ||||
| Primary | 03665851000103 | GS1 |
Customer Contacts
- Phone
- +33158281683
- [email protected]
- Phone
- +33158281683
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 4 | Inch | |
| Width | 4 | Inch |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 35 Degrees Celsius