Duns Number:002348191
Device Description: PUNCH DP-44K NON-STERILE 4.4 MILLIMETERS
Catalog Number
DP-44NS
Brand Name
PILLING
Version/Model Number
IPN011481
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
DWS
Product Code Name
INSTRUMENTS, SURGICAL, CARDIOVASCULAR
Public Device Record Key
82114323-e960-4b60-bb10-9746effc2107
Public Version Date
October 29, 2018
Public Version Number
2
DI Record Publish Date
September 15, 2018
Package DI Number
24026704604832
Quantity per Package
100
Contains DI Package
04026704604838
Package Discontinue Date
October 26, 2018
Package Status
Not 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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |