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Bite protector for intraluminal applicators
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GM11011470
Identity
- Trade Name
- Bite protector for intraluminal applicators EUDAMEDFDA UDI
- Generic Name
- Brachytherapy system remote afterloading source transfer tube FDA UDI
- Device Name
- Intraluminal Applicator Set EUDAMED
- Model / Reference
- GM11011470 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11011470 FDA UDI
- Primary DI / UDI-DI
- 00816389026155 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201093QB EUDAMED
- 510(k) Number
- K151022 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Brachytherapy system remote afterloading source transfer tube FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Bite protector for intraluminal applicators by Varian Medical Systems, Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 089947500201093QB | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (3)
- EUDAMED a323da32-a92d-4913-86fd-0a246f2142b7 61 fields · synced Jun 18, 2026
- FDA UDI 99e3ce96-5750-426e-8776-dc2051cbdb53 34 fields · synced May 30, 2026
- EUDAMED 8a54fd55-b939-42ea-a22a-4941fe3e1075 61 fields · synced Jun 18, 2026