Duns Number:103056420
Device Description: MICRO SAGITTAL NARROW BLADE
Catalog Number
-
Brand Name
MicroAire®
Version/Model Number
505332
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 30, 2021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GES
Product Code Name
Blade, Scalpel
Public Device Record Key
ff354da2-497d-42ac-88fe-29ef73140978
Public Version Date
January 06, 2022
Public Version Number
1
DI Record Publish Date
December 29, 2021
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 | 756 |
2 | A medical device with a moderate to high risk that requires special controls. | 190 |