Duns Number:315018218
Device Description: CHALLENGER TI-P Clip Applier Forceps, pneumatic, multi-fire, (260 mm), diam. 10 mm, consis CHALLENGER TI-P Clip Applier Forceps, pneumatic, multi-fire, (260 mm), diam. 10 mm, consisting of PL520R, PL538R, reusable, reposable, to be used with: PL575SU, PL579T
Catalog Number
PL608R
Brand Name
AESCULAP
Version/Model Number
PL608R
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
FZP
Product Code Name
CLIP, IMPLANTABLE
Public Device Record Key
3464fb44-96b4-4ed8-b3ae-06e175550b12
Public Version Date
October 19, 2021
Public Version Number
4
DI Record Publish Date
September 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 |