Identity
- Trade Name
- KOSMA-KARE FDA UDI
- Generic Name
- Cotton pleats FDA UDI
- Device Name
- RAYON COIL 6,4 gr per meter - 20LBS / CS FDA UDI
- Model / Reference
- J-2288 FDA UDI
- Description
- RAYON COIL 6,4 gr per meter - 20LBS / CS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10770619270343 FDA UDI
- FDA Product Code
- FRL FDA UDI
- GMDN Term
- Cotton pleats FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cotton pleats
Kosma-Kare by Kosma-Kare Canada Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cotton pleats.
- KOSMA-KARE — Kosma-Kare Canada Inc · Class I
- KOSMA-KARE — Kosma-Kare Canada Inc · Class I
- KOSMA-KARE — Kosma-Kare Canada Inc · Class I
- KOSMA-KARE — Kosma-Kare Canada Inc · Class I
- KOSMA-KARE — Kosma-Kare Canada Inc · Class I
- KOSMA-KARE — Kosma-Kare Canada Inc · Class I
- KOSMA-KARE — Kosma-Kare Canada Inc · Class I
- KOSMA-KARE — Kosma-Kare Canada Inc · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Kosma-Kare Canada Inc
Sources (1)
- FDA UDI 2accb5ce-47b0-4c2c-8a32-6cfdd9bccbeb 33 fields · synced May 30, 2026