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CT/MR M.A.C. Interstitial GYN Template, 15.5GElekta

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 1211-15.5Ref 1505-15.5Ref 1506-15.5

by Mick Radio Nuclear Instrument, Inc

Identity

Trade Name
CT/MR M.A.C. Interstitial GYN Template,15.5G Bebig EUDAMEDFDA UDI
CT/MR M.A.C. Interstitial GYN Template,15.5G Varian EUDAMED
CT/MR M.A.C. Interstitial GYN Template,15.5G Elekta EUDAMED
CT/MR M.A.C. Interstitial GYN Template,15.5GElekta FDA UDI
CT/MR M.A.C. Interstitial GYN Template, 15.5G FDA UDI
CT/MR M.A.C. Interstitial GYN Template,15.5GVarian FDA UDI
Generic Name
General-purpose brachytherapy system applicator, manual FDA UDI
Device Name
CT/MR M.A.C. Interstitial GYN Template Varian EUDAMED
CT/MR M.A.C. Interstitial GYN Template Elekta EUDAMED
CT/MR M.A.C. Interstitial GYN Template Bebig EUDAMED
Model / Reference
1505-15.5 EUDAMEDFDA UDI
1211-15.5 EUDAMEDFDA UDI
1506-15.5 EUDAMEDFDA UDI
1507-15.5 FDA UDI

Identifiers

Catalog Number
1505-15.5 FDA UDI
1507-15.5 FDA UDI
1211-15.5 FDA UDI
1506-15.5 FDA UDI
Primary DI / UDI-DI
00817330024152 EUDAMEDFDA UDI
00817330023599 EUDAMEDFDA UDI
00817330024190 EUDAMEDFDA UDI
00817330024244 FDA UDI
Basic UDI-DI
B-00817330023599 EUDAMED
B-00817330024152 EUDAMED
B-00817330024190 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 EUDAMED
Class 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

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Category: General-purpose brachytherapy system applicator, manual

CT/MR M.A.C. Interstitial GYN Template, 15.5GElekta by Mick Radio Nuclear Instrument, Inc — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED

Similar devices

Also classified as General-purpose brachytherapy system applicator, manual.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mick Radio Nuclear Instrument, Inc

Sources (7)

  • FDA UDI 42c7d2c8-045e-4557-929d-b45db285b877 33 fields · synced Jul 27, 2026
  • FDA UDI f4453aea-2124-462c-983d-591cbb12f247 33 fields · synced May 30, 2026
  • FDA UDI f8f16010-f315-4cf8-ae12-061f2499a044 33 fields · synced May 30, 2026
  • FDA UDI adddfbd8-44f6-4542-80a5-ba0f48e5b258 33 fields · synced May 30, 2026
  • EUDAMED 30178739-8f28-436a-b1bc-97c64eac61ee 61 fields · synced Jul 9, 2026
  • EUDAMED 3f8e600d-e669-4735-a54f-5e098e9611be 61 fields · synced Jul 16, 2026
  • EUDAMED 1460e50d-5290-4270-b473-02838e83e522 61 fields · synced Jul 27, 2026