Duns Number:506826739
Device Description: Applicator 170 mmfor bone grafting materialfront: Ø 3.5 mm Ø 2.5mm
Catalog Number
-
Brand Name
devemed
Version/Model Number
2405-1
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"
-
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
-
Product Code
MDM
Product Code Name
Instrument, Manual, Surgical, General Use
Public Device Record Key
51c08d6f-3c68-4ce4-b41a-36581ce8f0d5
Public Version Date
April 24, 2020
Public Version Number
1
DI Record Publish Date
April 16, 2020
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 | 2521 |