Duns Number:618749857
Catalog Number
-
Brand Name
EFFI+PRO PIN 2.4MM
Version/Model Number
20197
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
-
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
HWN
Product Code Name
Instrument, Compression
Public Device Record Key
cb3d7590-3f7e-4fa6-ac7f-3c2a356fc57e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 16, 2015
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 494 |
2 | A medical device with a moderate to high risk that requires special controls. | 2447 |