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Accessory Kit - "Light" Version for Interstitial Applicators

FDA UDI

Class II (US FDA UDI)

by Varian Medical Systems Deutschland GmbH

Identity

Trade Name
Accessory Kit - "Light" Version for Interstitial Applicators FDA UDI
Generic Name
General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
Model / Reference
GM11008660 FDA UDI

Identifiers

Catalog Number
GM11008660 FDA UDI
Primary DI / UDI-DI
00816389024670 FDA UDI
510(k) Number
K141336 FDA UDI
K141624 FDA UDI
K152018 FDA UDI
K983436 FDA UDI
FDA Product Code
JAQ FDA UDI
GMDN Term
General-purpose brachytherapy system applicator, remote-afterloading FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.5700 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: General-purpose brachytherapy system applicator, remote-afterloading

Accessory Kit - "Light" Version for Interstitial Applicators by Varian Medical Systems Deutschland GmbH — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as General-purpose brachytherapy system applicator, remote-afterloading.

Cleared under the same submission

K141336 also covers:

K141624 also covers:

K152018 also covers:

K983436 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Varian Medical Systems Deutschland GmbH

Sources (1)

  • FDA UDI c07ebfb4-f176-4ae1-8006-d85f0b49ae65 34 fields · synced May 30, 2026