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Isolator Disposable Cotton Roll Holder 50 Pack
EUDAMEDFDA UDIClass I (EU MDR)
Ref 28100
Identity
- Trade Name
- Isolator Disposable Cotton Roll Holder 50 Pack EUDAMEDFDA UDI
- Generic Name
- Dental cotton roll FDA UDI
- Device Name
- Miscellaneous Class I Dental Accessories EUDAMEDPlastic disposable cotton roll holder 50 pack. Each clamp firmly holds two cotton rolls, sizes 1,2 & 3. Provides a dry field without restricting access or visibility FDA UDI
- Model / Reference
- 28100 EUDAMEDFDA UDI
- Description
- Plastic disposable cotton roll holder 50 pack. Each clamp firmly holds two cotton rolls, sizes 1,2 & 3. Provides a dry field without restricting access or visibility FDA UDI
Identifiers
- Catalog Number
- 28-100 FDA UDI
- Primary DI / UDI-DI
- 00310866001470 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
- Germany 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 Disposable Cotton Roll Holder 50 Pack by Pascal Company, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 a109c573-1177-4306-9d78-5d15ef30d7be 61 fields · synced Jun 18, 2026
- FDA UDI 45b7bf36-317f-4634-804b-0fbb09abb9e9 35 fields · synced May 30, 2026