Duns Number:192135242
Device Description: PMI Push Button Pencil with PTFE coated blade & holster
Catalog Number
P0035H
Brand Name
PMI
Version/Model Number
P0035H
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
312cd377-b7db-44c9-954a-0dbb4e0653e8
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
10812608020727
Quantity per Package
25
Contains DI Package
00812608020720
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |