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Patient Barrier Aprons
EUDAMEDFDA UDIClass I (EU MDR)
Ref NP5WHModel Dental Towels and Bibs
Identity
- Trade Name
- Patient Barrier Aprons EUDAMEDFDA UDI
- Generic Name
- Isolation gown, single-use FDA UDI
- Device Name
- Plastic, Ankle Length (36 in x 54in), White FDA UDI
- Model / Reference
- Dental Towels and Bibs EUDAMEDNP5WH EUDAMEDFDA UDI
- Description
- Plastic, Ankle Length (36 in x 54in), White FDA UDI
Identifiers
- Catalog Number
- NP5WH FDA UDI
- Primary DI / UDI-DI
- 10732224004614 EUDAMEDFDA UDI
- Basic UDI-DI
- 0732224TowelsLZ EUDAMED
- FDA Product Code
- KHR FDA UDI
- EMDN Code
- T0306 PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES EUDAMED
- GMDN Term
- Isolation gown, single-use 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
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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Patient Barrier Aprons 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 | 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 ba1d6755-9767-4e2c-a8c9-092fa6abda6c 61 fields · synced Oct 6, 2026
- FDA UDI 1a42dbda-7d01-4779-82bb-70f25d2257ac 35 fields · synced May 30, 2026