Duns Number:315018218
Device Description: METZENBAUM ADTEC SINGLE USE Dissecting Scissors, complete instrument, monopolar, curved to METZENBAUM ADTEC SINGLE USE Dissecting Scissors, complete instrument, monopolar, curved to left, working length: 11 1/2", (290 mm),diam. 3,50 mm, rotatable, insulated, double action, sterile, disposable, package of 5 pieces
Catalog Number
PO830SU
Brand Name
AESCULAP
Version/Model Number
PO830SU
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
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
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
3f862cdf-03dc-4321-83b9-e884e1f26a75
Public Version Date
January 18, 2022
Public Version Number
8
DI Record Publish Date
October 10, 2016
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 |