Duns Number:058614483
Device Description: Perineal Packing - RF and X-ray Detectable Roll
Catalog Number
PPK-025YC-R
Brand Name
Situate
Version/Model Number
PPK-025YC-R
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
GDY
Product Code Name
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Public Device Record Key
bc89eaa0-3e16-4498-9961-a4219676f8e3
Public Version Date
August 24, 2021
Public Version Number
2
DI Record Publish Date
September 26, 2018
Package DI Number
20884521701028
Quantity per Package
200
Contains DI Package
10884521701021
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |