MTD 4000 Digital Traction - Mettler Traction Decompression system, head unit - METTLER ELECTRONICS CORP.

Duns Number:008513913

Device Description: Mettler Traction Decompression system, head unit

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More Product Details

Catalog Number

ME 4000

Brand Name

MTD 4000 Digital Traction

Version/Model Number

ME 4000

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"

Yes

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

K091540

Product Code Details

Product Code

ITH

Product Code Name

EQUIPMENT, TRACTION, POWERED

Device Record Status

Public Device Record Key

2efe9e04-77de-40fc-9600-f69b6c211e27

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"METTLER ELECTRONICS CORP." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 57