Baseplate - Baseplate - MEDTEC, INC.

Duns Number:103977526

Device Description: Baseplate

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


More Product Details

Catalog Number

MTVRB100

Brand Name

Baseplate

Version/Model Number

MTVRB100

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

-

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

K093738

Product Code Details

Product Code

LNH

Product Code Name

System, nuclear magnetic resonance imaging

Device Record Status

Public Device Record Key

6c7f2f7b-c200-4398-b519-38714fd1f09c

Public Version Date

May 31, 2021

Public Version Number

1

DI Record Publish Date

May 22, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTEC, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 31
2 A medical device with a moderate to high risk that requires special controls. 1027