Duns Number:108999095
Device Description: Thumb Dressing Forceps,5", Serrated, Disp pkg
Catalog Number
330Q
Brand Name
ADC®
Version/Model Number
330Q
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 09, 2019
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LRW
Product Code Name
Scissors, General, Surgical
Public Device Record Key
e00b228b-46a0-4423-affe-fa366bb449a2
Public Version Date
April 10, 2019
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
00634782820879
Quantity per Package
12
Contains DI Package
00634782020927
Package Discontinue Date
April 09, 2019
Package Status
Not in Commercial Distribution
Package Type
Inner pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2395 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1769 |