Metal Frame Table Insert, Elekta Precise - Aktina Corp.

Duns Number:787178920

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More Product Details

Catalog Number

-

Brand Name

Metal Frame Table Insert, Elekta Precise

Version/Model Number

11-205

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K993522

Product Code Details

Product Code

JAI

Product Code Name

Couch, Radiation Therapy, Powered

Device Record Status

Public Device Record Key

2d7627c2-efbf-4d01-b3df-c035028aea8c

Public Version Date

May 23, 2019

Public Version Number

5

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

-

"AKTINA CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 217