Duns Number:315018218
Device Description: METZENBAUM Dissecting Scissors, curved, working length: 10", (250 mm), diam. 7 mm, wave cu METZENBAUM Dissecting Scissors, curved, working length: 10", (250 mm), diam. 7 mm, wave cut, double action, non-sterile, reusable
Catalog Number
FC834W
Brand Name
AESCULAP
Version/Model Number
FC834W
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
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
54f78c2e-e674-4917-9015-55dba9ab98d7
Public Version Date
January 15, 2020
Public Version Number
2
DI Record Publish Date
April 30, 2019
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 |