Duns Number:007198742
Catalog Number
-
Brand Name
PKS LP Scissors 5mm/33cm
Version/Model Number
3804PK
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 21, 2017
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
K031081,K031081
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
34f49396-5283-463b-87e6-2aab91de636b
Public Version Date
August 03, 2022
Public Version Number
5
DI Record Publish Date
October 12, 2016
Package DI Number
00821925010765
Quantity per Package
5
Contains DI Package
00821925038011
Package Discontinue Date
March 21, 2017
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 899 |
2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
3 | A medical device with high risk that requires premarket approval | 9 |
U | Unclassified | 4 |