Duns Number:239403863
Device Description: The Blunt Dissector is used during laparoscopic procedures to provide a means for the safe The Blunt Dissector is used during laparoscopic procedures to provide a means for the safe atraumatic manipulation and dissection of tissue during abdominal investigation.
Catalog Number
PS3885
Brand Name
Blunt Dissector - 3 pack
Version/Model Number
PS3885
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
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
-
Product Code
GDI
Product Code Name
Dissector, Surgical, General & Plastic Surgery
Public Device Record Key
6de230c6-010f-4e43-b429-2529d34bf72f
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 17, 2016
Package DI Number
35051223004227
Quantity per Package
10
Contains DI Package
05051223004226
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
shipping carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 128 |