Identity
- Trade Name
- CareOne FDA UDI
- Generic Name
- Corn/callus dressing, single-use FDA UDI
- Device Name
- Hydrocolloid Blister Cushion, all one size, 1.65 IN x 2.67 IN (42 mm x 68 mm) FDA UDI
- Model / Reference
- 041520104861 FDA UDI
- Description
- Hydrocolloid Blister Cushion, all one size, 1.65 IN x 2.67 IN (42 mm x 68 mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00041520104861 FDA UDI
- FDA Product Code
- NAD FDA UDI
- GMDN Term
- Corn/callus dressing, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4020 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
CareOne by Ahold U.S.A., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ahold U.S.A., Inc.
Sources (1)
- FDA UDI 995ce6fe-6983-4bed-83b7-2f42c51ddc01 34 fields · synced May 30, 2026