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Isolator Mini Disposable Cotton Roll Holder 25 pack
EUDAMEDFDA UDIClass I (EU MDR)
Ref 28120
Identity
- Trade Name
- Isolator Mini Disposable Cotton Roll Holder 25 pack EUDAMEDIsolator Mini FDA UDI
- Generic Name
- Dental cotton roll FDA UDI
- Device Name
- Miscellaneous Class I Dental Accessories EUDAMEDPack of 25 Great for sealants & multiple situations when a dry field is necessary. Adapts to cotton roll sizes 1,2 & 3. Maintains a dry field without restricting access and visibility. Eliminates patient discomfort. FDA UDI
- Model / Reference
- 28120 EUDAMEDFDA UDI
- Description
- Pack of 25 Great for sealants & multiple situations when a dry field is necessary. Adapts to cotton roll sizes 1,2 & 3. Maintains a dry field without restricting access and visibility. Eliminates patient discomfort. FDA UDI
Identifiers
- Catalog Number
- 28120 FDA UDI
- Primary DI / UDI-DI
- 00310866002538 EUDAMEDFDA UDI
- Basic UDI-DI
- 03108666001GS EUDAMED
- FDA Product Code
- EFN FDA UDI
- EMDN Code
- Q019004 DENTAL COTTON ROLLS EUDAMED
- GMDN Term
- Dental cotton roll FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6050 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Isolator Mini Disposable Cotton Roll Holder 25 pack by Pascal Company, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 03108666001GS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Pascal Company Inc.
- EUDAMED SRN
- US-MF-000032036
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED b17a5a05-a245-44ba-b7dd-b81b5ca3746d 61 fields · synced Jun 19, 2026
- FDA UDI 87ff9bd3-ba6d-48e4-be98-055c83b1e31e 35 fields · synced May 30, 2026