Duns Number:007941230
Device Description: Speculum Vaginal Large Disposable Clear Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
Medichoice
Version/Model Number
VAG1003
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
K050887,K050887,K050887
Product Code
HIB
Product Code Name
Speculum, vaginal, nonmetal
Public Device Record Key
9010d992-1498-45c9-96a7-8671d2362361
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 20, 2016
Package DI Number
50885632101418
Quantity per Package
10
Contains DI Package
30885632101414
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |