Duns Number:315018218
Device Description: ADTEC SOVEREIGN Grasping Forceps, complete instrument, (360 mm), diam. 5 mm, with sliding ADTEC SOVEREIGN Grasping Forceps, complete instrument, (360 mm), diam. 5 mm, with sliding ratchet, single action, reusable
Catalog Number
PL054R
Brand Name
AESCULAP
Version/Model Number
PL054R
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 03, 2018
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
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
c4899c91-5b6c-4918-889c-5b2b0d7f997e
Public Version Date
January 19, 2022
Public Version Number
4
DI Record Publish Date
May 24, 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 |