Duns Number:315018218
Device Description: NOIR Brain Spatula, 8", (200 mm), double ended, flexible, extra wide, 21/11 mm, non-steril NOIR Brain Spatula, 8", (200 mm), double ended, flexible, extra wide, 21/11 mm, non-sterile, reusable
Catalog Number
FF459B
Brand Name
NOIR
Version/Model Number
FF459B
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
GAF
Product Code Name
SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY
Public Device Record Key
49a53a93-8efc-4752-98c2-b184b66b2051
Public Version Date
May 01, 2020
Public Version Number
1
DI Record Publish Date
April 23, 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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |