MR Adapter TRP-IV - Clinical Laserthermia Systems AB

Duns Number:774856749

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More Product Details

Catalog Number

-

Brand Name

MR Adapter TRP-IV

Version/Model Number

4013-07

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

Yes

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

GEA

Product Code Name

Cannula, Surgical, General & Plastic Surgery

Device Record Status

Public Device Record Key

69fa0d7e-f422-46f2-abd9-8fe29da2381f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 16, 2017

Additional Identifiers

Package DI Number

37340007000530

Quantity per Package

5

Contains DI Package

17340007000536

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"CLINICAL LASERTHERMIA SYSTEMS AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 14