← Back to catalogue
DermaDam Synthetic Sample - 2pk (2 Medium)
EUDAMEDFDA UDIClass I (EU MDR)
Ref DENTALFUPIBLU01800602Model Dental Dam
Identity
- Trade Name
- DermaDam Synthetic Sample - 2pk (2 Medium) EUDAMEDUltradent FDA UDI
- Generic Name
- Rubber dam, non-latex FDA UDI
- Device Name
- DermaDam Synthetic Sample - 2pk (2 Medium) FDA UDI
- Model / Reference
- Dental Dam EUDAMEDDENTALFUPIBLU01800602 EUDAMEDMedium FDA UDI
- Description
- DermaDam Synthetic Sample - 2pk (2 Medium) FDA UDI
Identifiers
- Catalog Number
- DENTALFUPIBLU01800602 FDA UDI
- Primary DI / UDI-DI
- 05060748681980 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
DermaDam Synthetic Sample - 2pk (2 Medium) by Four D Rubber Company Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rubber dam, Hevea-latex.
- Theraband, Tubing with Hard Handles, Green — The Hygenic Company, LLC · Class I
- Cranberry — ASCEND EAGLE INCORPORATED · Class I
- Medical Loops — Ningbo Jenius Polymer Sci-Tech Co.,Ltd · Class I
- TheraBand Exercise Band 2.5m Yellow in Zipper Bag with Retail Carton - EU — The Hygenic Company, LLC · Class I
- BANCO DE COLSON (2 PLAZAS) — ORTOTECSA,S.L. · Class I
- Theraband 25 Yard Non-Latex Black CE Mark — The Hygenic Company, LLC · Class I
- HYGENIC — Coltene/Whaledent Inc. · Class I
- HEDY DENTAL DAM — AMD Medicom Inc · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Four D Rubber Company Ltd
- EUDAMED SRN
- GB-MF-000012178
- Authorised Representative
- DEVMED International Limited IE-AR-000011607
Sources (2)
- EUDAMED b3391001-951a-49c5-87c1-1a1fd5d4ca58 61 fields · synced Oct 6, 2026
- FDA UDI 63454296-05db-48b3-bcc3-e0455e15eee6 35 fields · synced May 30, 2026