Duns Number:506826739
Device Description: Holder for micro bladesMod.1F-LINE SL single ended
Catalog Number
-
Brand Name
devemed
Version/Model Number
1145-30 F
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
GDZ
Product Code Name
Handle, Scalpel
Public Device Record Key
ba640de8-ef39-4b14-a861-e098d2f3b184
Public Version Date
April 14, 2020
Public Version Number
1
DI Record Publish Date
April 06, 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 |