Duns Number:008513913
Device Description: Mettler Traction Decompression system, head unit
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
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
ITH
Product Code Name
EQUIPMENT, TRACTION, POWERED
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 57 |