Wrap-Ease Cushions
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Wrap-Ease Cushions EUDAMEDWrap-Ease™ Cushions FDA UDI
- Generic Name
- Dental x-ray film holder, single-use FDA UDI
- Device Name
- X-Ray cushions FDA UDI
- Model / Reference
- Dental X-Ray Comfort Cushions EUDAMEDBWWEL EUDAMEDFDA UDI
- Description
- X-Ray cushions FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10732224003068 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224ImagingComfortPU EUDAMED
- Unit of Use DI
- 00732224003061 EUDAMED
- 510(k) Number
- K852170 FDA UDI
- FDA Product Code
- EGZ FDA UDI
- EMDN Code
- Z1103040102 EQUIPMENT FOR DIGITAL ENDORAL RADIOLOGY EUDAMED
- GMDN Term
- Dental x-ray film holder, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.1905 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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Dental digital imaging sensor, intraoral
Wrap-Ease Cushions by Crosstex International, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 0732224ImagingComfortPU | 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 23d0ddb5-4edd-40fa-a7b5-4c7ff3597124 61 fields · synced Sep 17, 2026
- FDA UDI 58490e74-1228-4379-9bd1-a059e917928e 35 fields · synced May 29, 2026