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ISODAM .28/.32mm X- Heavy - L.Blue 6" x 6" 15 pcs
EUDAMEDFDA UDIClass I (EU MDR)
Ref DENTALFGENISO02800615Model Dental Dam
Identity
- Trade Name
- ISODAM .28/.32mm X- Heavy - L.Blue 6" x 6" 15 pcs EUDAMEDISODAM FDA UDI
- Generic Name
- Rubber dam, non-latex FDA UDI
- Device Name
- ISODAM .28/.32mm X- Heavy - L.Blue 6" x 6" 15 pcs FDA UDI
- Model / Reference
- Dental Dam EUDAMEDDENTALFGENISO02800615 EUDAMEDX-Heavy FDA UDI
- Description
- ISODAM .28/.32mm X- Heavy - L.Blue 6" x 6" 15 pcs FDA UDI
Identifiers
- Catalog Number
- DENTALFGENISO02800615 FDA UDI
- Primary DI / UDI-DI
- 05060748681676 EUDAMEDFDA UDI
- Basic UDI-DI
- 5060748684DNLDD4J EUDAMED
- FDA Product Code
- EIE FDA UDI
- EMDN Code
- Y0504 ARMS, TORSO AND LEGS RE-EDUCATION DEVICES EUDAMED
- GMDN Term
- Rubber dam, non-latex FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6300 FDA UDI
- Market of Registration
- Ireland 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Rubber dam, Hevea-latex
ISODAM .28/.32mm X- Heavy - L.Blue 6" x 6" 15 pcs by Four D Rubber Company Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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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 | 5060748684DNLDD4J | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Four D Rubber Company Ltd
- EUDAMED SRN
- GB-MF-000012178
- Authorised Representative
- DEVMED International Limited IE-AR-000011607
Sources (2)
- EUDAMED 3b76bdcd-b227-4f04-b50a-5c48b548a1df 61 fields · synced Jun 18, 2026
- FDA UDI 474dc88e-6d41-4a54-9524-2cca31fd9a04 35 fields · synced May 29, 2026