Duns Number:831375089
Device Description: Ear & Ulcer Syringe, 2oz, DEHP Free, Sterile
Catalog Number
3610
Brand Name
PremierPro
Version/Model Number
3610
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
JYH
Product Code Name
Excavator, Ear
Public Device Record Key
0feb3035-9fbe-497f-95c7-110c54d99e8a
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
August 04, 2020
Package DI Number
10818566017717
Quantity per Package
50
Contains DI Package
00818566017710
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |