Duns Number:830016148
Device Description: 3M™ Precise™ Disposable Skin Stapler, Pistol-Grip PGX-15W
Catalog Number
PGX-15W
Brand Name
3M™ Precise™
Version/Model Number
PGX-15W
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
GDT
Product Code Name
STAPLE, REMOVABLE (SKIN)
Public Device Record Key
4a87900e-6f32-44ec-b1f3-6d841c8e201b
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
September 25, 2018
Package DI Number
50707387070194
Quantity per Package
4
Contains DI Package
30707387070190
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |