FDA UDI
In Commercial Distribution
🇺🇸 United States
KOSMA-KARE
DI: 10770619270367
·
Model: KC-2287
·
Kosma-Kare Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KOSMA-KARE
- Primary DI
- 10770619270367
- Version / Model
- KC-2287
- Company Name
- Kosma-Kare Canada Inc
- Labeler DUNS
- 248955460
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-16
- Public Version
- 2
- Public Version Date
- 2020-11-06
- Public Version Status
- Update
- Public Device Record Key
- 0c94d4fb-2402-48e5-bcfa-729e0d26d0c0
Device Description
COTTON COIL 9.8G/Y - 22LBS / CS
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FRL | Fiber, Medical, Absorbent | General Hospital | 880.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58234 | Cotton pleats | A device designed as an absorbent 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 intended for use in the home or healthcare facility. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10770619270367 | GS1 |