Identity
- Trade Name
- Crosstex Dental Dams EUDAMEDDental Dams FDA UDI
- Generic Name
- Rubber dam, Hevea-latex FDA UDI
- Device Name
- Dental Dam Natural Latex, Unflavored, 5" x 5", Heavy FDA UDI
- Model / Reference
- Dental Dam EUDAMED19101 EUDAMEDFDA UDI
- Description
- Dental Dam Natural Latex, Unflavored, 5" x 5", Heavy FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10732224002177 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224DentalDamTX EUDAMED
- Unit of Use DI
- 00732224002170 EUDAMED
- FDA Product Code
- EIE FDA UDI
- EMDN Code
- Q019002 DENTISTRY DAMS AND HOOKS, SINGLE-USE EUDAMED
- GMDN Term
- Rubber dam, Hevea-latex FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.6300 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Crosstex Dental Dams by Crosstex International, 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 | 0732224DentalDamTX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Crosstex International Inc
- EUDAMED SRN
- US-MF-000009642
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 2531c115-fcc3-4819-8c34-542859aed9a5 61 fields · synced Oct 6, 2026
- FDA UDI d755f212-1722-4408-a1c2-871eb37e6dff 35 fields · synced May 30, 2026