Duns Number:009831413
Device Description: Pro Advantage Speculum Vaginal MD 10/BG 10BG/CS
Catalog Number
P250200
Brand Name
Pro Advantage
Version/Model Number
P250200
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HIB
Product Code Name
Speculum, Vaginal, Nonmetal
Public Device Record Key
605820eb-6838-43ab-80f8-be6e5e4fc021
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 13, 2017
Package DI Number
M220P2502005
Quantity per Package
100
Contains DI Package
M220P5202002
Package Discontinue Date
-
Package Status
-
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 224 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 192 |