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Disposable Loop-X Source Drape (1 Pc)
EUDAMEDFDA UDIClass I (EU MDR)
Ref 22183-12
by Brainlab SE
Identity
- Trade Name
- Disposable Loop-X Source Drape (1 Pc) EUDAMEDDisposable Loop-X Source Drape (1 Pc) FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- Disposable Loop-X Drape EUDAMEDThe source drape is intended to sterile cover the source (cone beam) of the Loop-X. FDA UDI
- Model / Reference
- 22183-12 EUDAMEDFDA UDI
- Description
- The source drape is intended to sterile cover the source (cone beam) of the Loop-X. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04056481146009 EUDAMEDFDA UDI
- Basic UDI-DI
- 4056481Drape9P EUDAMED
- FDA Product Code
- PUI FDA UDI
- EMDN Code
- T020199 SURGICAL DRAPES - OTHER EUDAMED
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
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
Disposable Loop-X Source Drape (1 Pc) by Brainlab SE — 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 | 4056481Drape9P | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Brainlab SE
- EUDAMED SRN
- DE-MF-000006183
Sources (2)
- EUDAMED e85a8455-8be2-4ff8-bb57-8e0fe524d9d1 61 fields · synced Jun 19, 2026
- FDA UDI 7a5ef19e-ea20-4a6c-a213-032b855c8660 33 fields · synced May 30, 2026