Identity
- Trade Name
- Henry Schein EUDAMEDFDA UDI
- Generic Name
- Rubber dam, Hevea-latex FDA UDI
- Device Name
- Non Latex Dental Dam EUDAMEDSCHEIN NON LATEX DAM 6X6 PURPLE HEAVY PLAIN (0.30MM) FDA UDI
- Model / Reference
- TF-372(HS) EUDAMED5701622 EUDAMEDFDA UDI
- Description
- SCHEIN NON LATEX DAM 6X6 PURPLE HEAVY PLAIN (0.30MM) FDA UDI
Identifiers
- Catalog Number
- 5701622 FDA UDI
- Primary DI / UDI-DI
- 10304040082024 EUDAMEDFDA UDI
- Basic UDI-DI
- 03040437201CV EUDAMED
- Unit of Use DI
- 00304040082027 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
- Not 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
Yes
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
Henry Schein by Henry Schein, 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 | 03040437201CV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Henry Schein Inc.
- EUDAMED SRN
- US-MF-000021683
- Authorised Representative
- Henry Schein Services GmbH DE-AR-000008001
Sources (2)
- EUDAMED f9db38df-4f19-4332-9d18-7484c1c6f986 61 fields · synced Jul 9, 2026
- FDA UDI 9acc6d7f-6c65-4978-aa00-1698ed8386c1 35 fields · synced May 30, 2026