Duns Number:315018218
Device Description: AACHEN Brain Spatula, 7 7/8", (200 mm), double ended, malleable, 10/11 mm, non-sterile, re AACHEN Brain Spatula, 7 7/8", (200 mm), double ended, malleable, 10/11 mm, non-sterile, reusable
Catalog Number
FF442R
Brand Name
AESCULAP
Version/Model Number
FF442R
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
6dded95b-183b-4136-a4cb-2f0302b1c27f
Public Version Date
May 14, 2020
Public Version Number
1
DI Record Publish Date
May 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 | 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 |