Duns Number:690340653
Catalog Number
-
Brand Name
IMEDICOM SAW BLADE
Version/Model Number
KAS-940D
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GFA
Product Code Name
Blade, Saw, General & Plastic Surgery, Surgical
Public Device Record Key
2bf3eba8-f611-4a02-ba95-952f49d78c07
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
July 13, 2018
Package DI Number
08800038019072
Quantity per Package
10
Contains DI Package
08809317172149
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2527 |
2 | A medical device with a moderate to high risk that requires special controls. | 59 |