Duns Number:315018218
Device Description: Scalpel, 6 1/2", (165 mm), polymer handle, Fig. 65, stainless steel, blue, sterile, dispos Scalpel, 6 1/2", (165 mm), polymer handle, Fig. 65, stainless steel, blue, sterile, disposable, package of 5 pieces
Catalog Number
BA365
Brand Name
AESCULAP
Version/Model Number
BA365
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 20, 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
GDX
Product Code Name
SCALPEL, ONE-PIECE
Public Device Record Key
f3139618-222d-4041-9b52-ff3492a8faed
Public Version Date
February 28, 2022
Public Version Number
2
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 |