Duns Number:831375089
Device Description: PremierPro Vaginal Specula, Non-Sterile, Non-Lighted, Large
Catalog Number
5302
Brand Name
PremierPro
Version/Model Number
5302
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)
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
46472b3b-b3d2-473f-9787-10b3303482d8
Public Version Date
May 07, 2020
Public Version Number
1
DI Record Publish Date
April 29, 2020
Package DI Number
20818566017455
Quantity per Package
20
Contains DI Package
00818566017451
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 486 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 177 |
| U | Unclassified | 1 |