Duns Number:192135242
Device Description: PMI Tungsten Micro Needle 3cm 45° Angle, 3 mm from tip
Catalog Number
P1652
Brand Name
PMI
Version/Model Number
P1652
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
011c782a-4a07-4c84-a065-b4517140560d
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 08, 2019
Package DI Number
00812608021956
Quantity per Package
10
Contains DI Package
00812608021949
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 |