Duns Number:198227881
Device Description: BOX OF VAGINAL SPECS
Catalog Number
D586021
Brand Name
Welch Allyn, Inc.
Version/Model Number
901071
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
-
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
HIB
Product Code Name
Speculum, vaginal, nonmetal
Public Device Record Key
c85f0e56-6d6b-465f-848f-95f77a93a95a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 05, 2017
Package DI Number
00732094102857
Quantity per Package
1
Contains DI Package
00732094147711
Package Discontinue Date
October 27, 2016
Package Status
Not 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 | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |