Duns Number:831375089
Device Description: PremierPro Lap Sponge 4"x18" Sterile, 5/pk
Catalog Number
X8415
Brand Name
PremierPro
Version/Model Number
X8415
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
GDY
Product Code Name
Gauze/Sponge, Internal, X-Ray Detectable
Public Device Record Key
278a09bc-4983-472c-b538-c0c49d2ce921
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
August 25, 2020
Package DI Number
10818566010596
Quantity per Package
40
Contains DI Package
00818566010599
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 |