Duns Number:315018218
Device Description: Vascular Spatula, slightly curved, 9", (230 mm), blunt, round handle, width: 1,700 mm, non Vascular Spatula, slightly curved, 9", (230 mm), blunt, round handle, width: 1,700 mm, non-sterile, reusable
Catalog Number
FD333R
Brand Name
AESCULAP
Version/Model Number
FD333R
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
254feb16-cc8d-4287-bffb-085254030945
Public Version Date
July 20, 2021
Public Version Number
2
DI Record Publish Date
April 22, 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 |