MR Cannula - Clinical Laserthermia Systems AB

Duns Number:774856749

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

MR Cannula

Version/Model Number

4013-05

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

7432cc39-79f8-4acf-baae-d43d8fb6c818

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 06, 2016

Additional Identifiers

Package DI Number

57340007000473

Quantity per Package

10

Contains DI Package

17340007000475

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