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Heyman Packing Applicator Set
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref GM11005410
Identity
- Trade Name
- Heyman Packing Applicator Set EUDAMEDHeyman Packing Applicator Set (CT & MR compatible) FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Heyman Packing Applicator Set EUDAMED
- Model / Reference
- GM11005410 EUDAMEDGM11004580 FDA UDI
Identifiers
- Catalog Number
- GM11004580 FDA UDI
- Primary DI / UDI-DI
- 00816389023222 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201035PV EUDAMED
- 510(k) Number
- K983436 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Heyman Packing Applicator Set by Varian Medical Systems, Inc — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241386 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K160045 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 089947500201035PV | Class IIa | Active |
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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 927ff5c6-2788-42da-bca2-8ad1fc3b4c14 61 fields · synced Jul 19, 2026
- FDA UDI b2ddf521-63c9-49e9-b6f0-de2e1eb15a71 34 fields · synced May 27, 2026
- FDA 510(k) K241386 1 fields · synced May 18, 2026