Duns Number:315018218
Device Description: ZENKER Dissecting a. Ligature Forceps, curved, 13 3/4", (350 mm), fine, non-sterile, reusa ZENKER Dissecting a. Ligature Forceps, curved, 13 3/4", (350 mm), fine, non-sterile, reusable
Catalog Number
BJ134R
Brand Name
AESCULAP
Version/Model Number
BJ134R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 13, 2022
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
HTD
Product Code Name
FORCEPS
Public Device Record Key
77a217d0-6a30-417b-be0d-e96e33aa969e
Public Version Date
July 18, 2022
Public Version Number
2
DI Record Publish Date
July 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 |