Duns Number:315018218
Device Description: CHALLENGER TI-P Clip Applier Forceps, pneumatic, multi-fire, (310 mm), diam. 5 mm, consist CHALLENGER TI-P Clip Applier Forceps, pneumatic, multi-fire, (310 mm), diam. 5 mm, consisting of PL520R, PL522R, reusable, reposable, to be used with: PL574T, PL575SU
Catalog Number
PL604R
Brand Name
CHALLENGER TI-P
Version/Model Number
PL604R
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
d59335e8-283a-46d2-9779-40ba241fd25f
Public Version Date
October 21, 2021
Public Version Number
5
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 |