Polyback Towels
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Polyback Towels EUDAMEDPolyback™ Towels FDA UDI
- Generic Name
- Dental bib FDA UDI
- Device Name
- Towels, Silver Grey, 3 Ply Tissue with 1 Ply Poly, 19 in x 13 in FDA UDI
- Model / Reference
- Dental Towels and Bibs EUDAMEDWPXSI EUDAMEDFDA UDI
- Description
- Towels, Silver Grey, 3 Ply Tissue with 1 Ply Poly, 19 in x 13 in FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50732224001314 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224TowelsLZ EUDAMED
- Unit of Use DI
- 00732224001319 EUDAMED
- FDA Product Code
- KHR FDA UDI
- EMDN Code
- T0306 PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES EUDAMED
- GMDN Term
- Dental bib 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Radiation/mechanical corneal shield, reusable
Polyback Towels are a high-quality, reliable dental towel and bib system designed for medical professionals to provide optimal patient care. This device meets the latest standards for infection control and is ideal for use in hospitals, clinics, and other healthcare settings.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0732224TowelsLZ | 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 140aa7ca-c5c3-4fdf-9a60-09cc856c1e12 61 fields · synced Aug 1, 2026
- FDA UDI 066d33b3-5f5a-4b4c-97d8-7a64f1259942 34 fields · synced May 30, 2026