Duns Number:832696038
Device Description: Wet PVP I Vaginal Preoperative Skin Prep Tray 4 oz. Bottle of Povidone Iodine Cleansing So Wet PVP I Vaginal Preoperative Skin Prep Tray 4 oz. Bottle of Povidone Iodine Cleansing Solution (Scrub) USP 7.5% and 4 oz. Bottle of Povidone Iodine Topical Solution (Paint) USP 10% with Powder-Free Gloves
Catalog Number
4469A
Brand Name
NA
Version/Model Number
4469A
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HGD
Product Code Name
APPLICATOR, VAGINAL
Public Device Record Key
d66d62a1-c0c0-4a13-90ae-e98345086ed3
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
July 18, 2018
Package DI Number
50885403184480
Quantity per Package
10
Contains DI Package
10885403184482
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |