CT/MR M.A.C. Interstitial GYN Template, 17G Elekta
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- CT/MR M.A.C. Interstitial GYN Template,17G Elekta EUDAMEDFDA UDICT/MR M.A.C. Interstitial GYN Template,17G Bebig EUDAMEDFDA UDICT/MR M.A.C. Interstitial GYN Template, 17G EUDAMEDFDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, manual FDA UDI
- Device Name
- CT/MR M.A.C. Interstitial GYN Template EUDAMEDCT/MR M.A.C. Interstitial GYN Template Bebig EUDAMEDCT/MR M.A.C. Interstitial GYN Template Elekta EUDAMED
- Model / Reference
- 1505-17 EUDAMEDFDA UDI1506-17 EUDAMEDFDA UDI1507-17 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 1505-17 FDA UDI1506-17 FDA UDI1507-17 FDA UDI
- Primary DI / UDI-DI
- 00817330024169 EUDAMEDFDA UDI00817330024206 EUDAMEDFDA UDI00817330024251 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00817330024251 EUDAMEDB-00817330024206 EUDAMEDB-00817330024169 EUDAMED
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- General-purpose brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
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
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: General-purpose brachytherapy system applicator, manual
CT/MR M.A.C. Interstitial GYN Template, 17G Elekta by Mick Radio Nuclear Instrument, Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Mick Radio Nuclear Instrument, Inc
Sources (6)
- FDA UDI a49bfa10-55e1-4ec7-b98d-a8a89720f503 33 fields · synced Oct 5, 2026
- FDA UDI cde39e7b-9f0f-4810-9ba5-cde195b6bf41 33 fields · synced May 30, 2026
- FDA UDI fc0aa1f6-66f0-44d0-a26d-a72ccec0dfa7 33 fields · synced May 30, 2026
- EUDAMED baf2a000-c7f6-4819-8c88-fc02da3fb827 61 fields · synced Jul 21, 2026
- EUDAMED 62c4c5be-98d4-44fe-9b58-7a99b8ab5b01 61 fields · synced Jul 21, 2026
- EUDAMED 5ba2773b-33fa-486d-9350-e975b583c303 61 fields · synced Aug 4, 2026