NA - Applicator 16 x 8 - ELEKTA LIMITED

Duns Number:525557559

Device Description: Applicator 16 x 8

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More Product Details

Catalog Number

-

Brand Name

NA

Version/Model Number

1525339

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IYE

Product Code Name

Accelerator, linear, medical

Device Record Status

Public Device Record Key

4e2834db-c6d0-4ce3-9069-b14d24ac3ae2

Public Version Date

August 12, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ELEKTA LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 50